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Recalls affecting Kansas

Data last updated: September 10, 2026 at 1:16 PM UTC

16,717 recalls found
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Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

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UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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UnclassifiedAnnounced September 3, 2026

B. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

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UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

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UnclassifiedAnnounced September 3, 2026

American Regent, Inc. — Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

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Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

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UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

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UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

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UnclassifiedAnnounced August 31, 2026

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

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Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

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UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

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Wording
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Devices which did not undergo thermoforming could deform and lose performance.

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FDA has not published a risk classification for this recall yet.

Recall #:
98252
Lot/product code:
Model/Catalog Number: KD-431Q-0720; Material REF: (1) 5859230, (2) N6221831, (3) N6221840; UDI-DI: (1) 04953170042362, (2) 04953170463778, (3) 04953170466564; All Lots with a valid expiration date
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326B; 4) DRAWER #5, Model Number: ACC010475; 5) DRAWER 1 NEURO CART, Model Number: ACC010542; 6) DRAWER 2 NEURO CART, Model Number: ACC010543; 7) DRAWER 4, Model Number: ACC010722; 8) SUCTION TRAY, Model Number: ACC010862; 9) MALIGNANT HYPERTHERMIA CART, Model Number: ACC010896;

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

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FDA has not published a risk classification for this recall yet.

Recall #:
98642
Lot/product code:
1) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 21CDB175; 2) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 21CDB692; 3) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 21LDA438; 4) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 22BDB172; 5) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 22HDA973; 6) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 23ADA426; 7) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 23BDA230; 8) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 23CDC052; 9) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 23CDA732; 10) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 23IDB293; 11) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 23LDB309; 12) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 23LDB516; 13) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 24ADA088; 14) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 24ADA521; 15) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 24ADB169; 16) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 24EDB837; 17) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 24GDA256; 18) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 24IDA878; 19) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 24JDB721; 20) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 24LDA585; 21) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 24LDA831; 22) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 25ADB193; 23) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 25BDB349; 24) ACC010326B, UDI-DI: 10198459292415(each), 40198459292416(case), Lot Number: 25CDB013; 25) ACC010326B, UDI-DI: 10198459292415(each), 40198459292416(case), Lot Number: 25CDB192; 26) ACC010326B, UDI-DI: 10198459292415(each), 40198459292416(case), Lot Number: 25DDA331; 27) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 21BDA319; 28) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 22JDB707; 29) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 22KDB086; 30) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 22LDA361; 31) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 23EDA657; 32) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 23EDB192; 33) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 23EDC028; 34) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 23KDB009; 35) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 24CDA302; 36) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 24DDB115; 37) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 24DDB561; 38) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 24IDB266; 39) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 25ADA506; 40) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 25CDA517; 41) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 25CDB100; 42) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 25FDA012; 43) ACC010542, UDI-DI: 10193489997279(each), 40193489997270(case), Lot Number: 21KDA051; 44) ACC010542, UDI-DI: 10193489997279(each), 40193489997270(case), Lot Number: 22DDB648; 45) ACC010542, UDI-DI: 10193489997279(each), 40193489997270(case), Lot Number: 22FDB178; 46) ACC010542, UDI-DI: 10193489997279(each), 40193489997270(case), Lot Number: 23JDA838; 47) ACC010542, UDI-DI: 10193489997279(each), 40193489997270(case), Lot Number: 24DDA266; 48) ACC010542, UDI-DI: 10193489997279(each), 40193489997270(case), Lot Number: 24JDA052; 49) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 24ADB837; 50) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 21KDB787; 51) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 22CDA899; 52) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 22EDA459; 53) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 23CDB042; 54) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 23JDB732; 55) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 24ADA075; 56) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 24JDA205; 57) ACC… (truncated, 224554 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6) TOTAL KNEE CDS-LF, Model Number: CDS980833Q; 7) TOTAL KNEE CDS-LF, Model Number: CDS980833R; 8) TOTAL HIP PROCEDURE, Model Number: CDS980865V; 9) TOTAL HIP PROCEDURE, Model Number: CDS980865W; 10) TOTAL HIP PROCEDURE, Model Number: CDS980865X; 11) TOTAL HIP PROCEDURE, Model Number: CDS980865Y; 12) TOTAL KNEE CDS, Model Number: CDS981454K; 13) TOTAL KNEE CDS, Model Number: CDS981454L; 14) KNEE ARTHROSCOPY CDS, Model Number: CDS981502K; 15) TOTAL KNEE, Model Number: CDS981505O; 16) TOTAL KNEE, Model Number: CDS981505P; 17) TOTAL KNEE, Model Number: CDS981505Q; 18) TOTAL KNEE, Model Number: CDS981505R; 19) OR LAMINECTOMY CDS, Model Number: CDS981858F; 20) LAMI FUSION, Model Number: CDS982035W; 21) ARMC TOTAL KNEE CDS, Model Number: CDS982281O; 22) ARMC TOTAL KNEE CDS, Model Number: CDS982281P; 23) ARMC TOTAL KNEE CDS, Model Number: CDS982281S; 24) TOTAL HIP CDS, Model Number: CDS983036K; 25) TOTAL KNEE CDS, Model Number: CDS983042K; 26) LOWER EXTREMITY CDS, Model Number: CDS983049K; 27) ZALE SPINE CDS, Model Number: CDS983182G; 28) TOTAL KNEE CDS, Model Number: CDS983297M; 29) SITTING CERVICAL CDS, Model Number: CDS983480G; 30) SHOULDER CDS, Model Number: CDS983581K; 31) SHOULDER ARTHROSCOPY CDS, Model Number: CDS983838G; 32) TOTAL HIP CDS, Model Number: CDS983840I; 33) TOTAL JOINT CDS-LF, Model Number: CDS983863D; 34) SHOULDER ARTHROSCOPY CDS, Model Number: CDS983879C; 35) TOTAL JOINT, Model Number: CDS983903D; 36) GB TOTAL KNEE, Model Number: CDS984147K; 37) GB LOWER EXTREMITY, Model Number: CDS984156L; 38) LOWER EXTREMTIY, Model Number: CDS984254K; 39) LOWER EXTREMTIY, Model Number: CDS984254L; 40) LOWER EXTREMTIY, Model Number: CDS984254M; 41) LAMI MICRODISC-LF, Model Number: CDS984527I; 42) EXTREMITY CDS-LF, Model Number: CDS984607G; 43) EXTREMITY CDS-LF, Model Number: CDS984607I; 44) HANA/FRACTURE TABLE CDS-LF, Model Number: CDS984610C; 45) TOTAL JOINT CDS, Model Number: CDS985202B; 46) TOTAL JOINT CDS, Model Number: CDS985202C; 47) TRAUMA-LF, Model Number: CDS985279K; 48) ARTHROSCOPY CDS, Model Number: CDS985316A; 49) EXTREMITY CDS, Model Number: CDS985317C; 50) EXTREMITY CDS, Model Number: CDS985317D; 51) EXTREMITY CDS, Model Number: CDS985317F; 52) EXTREMITY CDS, Model Number: CDS985317G; 53) KNEE ARTHROSCOPY CDS, Model Number: CDS985425J; 54) TOTAL HIP PACK (CDSOPM834)-LF, Model Number: CDSOPM834W; 55) JOINT ASPIRATION KIT, Model Number: DYKM1161; 56) TOTAL KNEE SUPPLEMENT PACK NS, Model Number: DYKM2106; 57) KIT ORTHRO TOTAL HIP DR. NANDI, Model Number: DYKMBNDL137; 58) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138A; 59) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141; 60) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141A; 61) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141B; 62) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142C; 63) KIT NEURO CRANIOTOMY ACOUSTIC, Model Number: DYKMBNDL143; 64) KIT NEURO CRANIOTOMY FOR TUMOR, Model Number: DYKMBNDL144; 65

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

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▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98329
Lot/product code:
1) CDS940087AG, UDI-DI: 10193489847260(each), 40193489847261(case), Lot Number: 21EBC900; 2) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22GBE442; 3) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22EBG548; 4) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22EBF695; 5) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22EBA274; 6) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22BBY060; 7) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 21KBH163; 8) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 21JBF936; 9) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 21IBJ260; 10) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 21GBI183; 11) CDS980832Q, UDI-DI: 10193489788655(each), 40193489788656(case), Lot Number: 21FBS254; 12) CDS980832Q, UDI-DI: 10193489788655(each), 40193489788656(case), Lot Number: 21BBL223; 13) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21LBO219; 14) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21KBQ650; 15) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21KBB625; 16) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21IBV695; 17) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21IBU197; 18) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21GBR895; 19) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23JBI054; 20) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23GBP400; 21) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23EBW653; 22) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23DBR887; 23) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23CBG614; 24) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23BBK758; 25) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23BBJ844; 26) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22OBK666; 27) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22OBI093; 28) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22JBH355; 29) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22HBS531; 30) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22GBM598; 31) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22GBL549; 32) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22GBK859; 33) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22GBK858; 34) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21LBL968; 35) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21LBC616; 36) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21KBF393; 37) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21JBO077; 38) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21GBV804; 39) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21GBB808; 40) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23EBK295; 41) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23CBT556; 42) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23BBP326; 43) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23ABH483; 44) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23ABG351; 45) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22IBE748; 46) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22GBS173; 47) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22GBS172; 48) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22FBD583; 49) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22DBN516; 50) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 21LBW480; 51) CDS980865V, UDI-DI: 10193489304206(each), 40193489304207(case), Lot Number: 21FBH003; 52) CDS980865V, UDI-DI: 10193489304206(each), 40193489304207(case), Lot Number: 21ABX303; 53) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 22OBL581; 54) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 22IMH323; 55) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 22GBM603; 56) CDS980865W, UDI-DI: 10193489929157(each), 401… (truncated, 261513 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O; 4) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A; 5) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116A; 6) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116G; 7) ROBOTIC PACK, Model Number: DYNJ04135B; 8) MINOR LITHOTOMY PACK, Model Number: DYNJ04382J; 9) NBMC D & C PACK-LF, Model Number: DYNJ0665843C; 10) D&C PACK-LF, Model Number: DYNJ22567G; 11) D&C PACK-LF, Model Number: DYNJ22567J; 12) D AND C, Model Number: DYNJ41272B; 13) D AND C, Model Number: DYNJ41272C; 14) OB PACK, Model Number: DYNJ42884; 15) D&C/GYN PACK, Model Number: DYNJ47713A; 16) PERI GYN PACK, Model Number: DYNJ55377D; 17) ANTERIOR CERVICAL-LF, Model Number: DYNJ58344; 18) D&C PACK, Model Number: DYNJ67214D; 19) D&C PACK, Model Number: DYNJ67214F; 20) D&C PACK, Model Number: DYNJ67214G; 21) D&C PACK, Model Number: DYNJ67214I; 22) LITHOTOMY PACK, Model Number: DYNJ80765C; 23) GYN PACK, Model Number: DYNJ83475; 24) D AND C PACK, Model Number: DYNJ87468; 25) D&C-ASC, Model Number: DYNJ900465C; 26) D&C-ASC, Model Number: DYNJ900465D; 27) D&C-ASC, Model Number: DYNJ900465F; 28) GYN LITHOTOMY-LF, Model Number: DYNJ902711L; 29) GYN LITHOTOMY-LF, Model Number: DYNJ902711N; 30) D&C, Model Number: DYNJ906947C; 31) PACK PERI GYN DSMC, Model Number: DYNJT6424

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

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FDA has not published a risk classification for this recall yet.

Recall #:
98329
Lot/product code:
1) CDS982407N, UDI-DI: 10193489683004(each), 40193489683005(case), Lot Number: 21DBO201; 2) CDS982407N, UDI-DI: 10193489683004(each), 40193489683005(case), Lot Number: 21CBD150; 3) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23GBM332; 4) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23GBL932; 5) CDS985431O, UDI-DI: 10198459195006(each), 40198459195007(case), Lot Number: 25GBB847; 6) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21IBS290; 7) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21GBE967; 8) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21FBB105; 9) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21DBC065; 10) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21CBQ508; 11) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22HBE127; 12) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22GBL821; 13) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22FBM235; 14) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22FBC878; 15) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22EBP063; 16) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22EBP060; 17) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21KBQ697; 18) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21HBB549; 19) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21FBB101; 20) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21DBE919; 21) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25GBG086; 22) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25EBM426; 23) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25BBI842; 24) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25ABF361; 25) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 24LBH410; 26) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 24LBE008; 27) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 24KBD429; 28) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23KBH005; 29) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23CBK988; 30) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 20XBF598; 31) DYNJ04382J, UDI-DI: 10195327271763(each), 40195327271764(case), Lot Number: 22JMI206; 32) DYNJ0665843C, UDI-DI: 10195327461041(each), 40195327461042(case), Lot Number: 23LBR468; 33) DYNJ0665843C, UDI-DI: 10195327461041(each), 40195327461042(case), Lot Number: 23JBL141; 34) DYNJ22567G, UDI-DI: 10193489267877(each), 40193489267878(case), Lot Number: 21DBJ206; 35) DYNJ22567G, UDI-DI: 10193489267877(each), 40193489267878(case), Lot Number: 21ABL629; 36) DYNJ22567G, UDI-DI: 10193489267877(each), 40193489267878(case), Lot Number: 21ABK140; 37) DYNJ22567J, UDI-DI: 10195327524876(each), 40195327524877(case), Lot Number: 24FBJ094; 38) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 23GMF146; 39) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 23EME955; 40) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 23AMG245; 41) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 23AMG044; 42) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 22GME486; 43) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 22DMD888; 44) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 22AME935; 45) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21LMB348; 46) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21IMB245; 47) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21GMF389; 48) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21FMA773; 49) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21DME541; 50) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21BMB150; 51) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21AMA560; 52) DYNJ41272C, UDI-DI: 10195327487409(each), 40195327487400(case), Lot Number: 23IMA347; 53) DYNJ42884, UDI-DI: 10888277011076(each), 40888277011077(case), Lot Number: 23CBJ945; 54) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 24GBW285; 55) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 24FBB582; 56) DYNJ4771… (truncated, 11901 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Devices which did not undergo thermoforming could deform and lose performance.

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FDA has not published a risk classification for this recall yet.

Recall #:
98252
Lot/product code:
Model/Catalog Number: KD-V411M-0320; Material REF: (1) N1089430, (2) N1089410, (3) N5411130; UDI-DI: (1) 04953170183973, (2) 04953170466274, (3) 04953170380556; All Lots with a valid expiration date
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;

If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be lost or incorrectly linked to other patients.

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FDA has not published a risk classification for this recall yet.

Recall #:
98753
Lot/product code:
Software Versions: 3.4.0 up to 3.9.5. UDI-DI: 04260495880341, 04260495880358, 04260495880365, 04260495880372, 04260495880389, 04260495880396.
Recalling firm:
Mint Medical GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER #5, Model Number: ACC010475; 4) DRAWER 1 NEURO CART, Model Number: ACC010542; 5) DRAWER 2 NEURO CART, Model Number: ACC010543; 6) DRAWER 4, Model Number: ACC010722; 7) MALIGNANT HYPERTHERMIA CART, Model Number: ACC010896; 8) LIVER TRANSPLANT #57 CDS-2, Model Number: CDS860063U; 9) THOROCOTOMY CDS #24-RF, Model Number: CDS860066T; 10) CYSTO, Model Number: CDS981795G; 11) MAJOR PROCEDURE CDS, Model Number: CDS982414N; 12) TOTAL KNEE CDS, Model Number: CDS982823R; 13) VASCULAR CDS-1, Model Number: CDS982895I; 14) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069F; 15) HEART CABG CDS, Model Number: CDS983376S; 16) CRANIOTOMY, Model Number: CDS983611N; 17) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653K; 18) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653L; 19) CUH KIDNEY TRANSPLANT CDS, Model Number: CDS983653M; 20) MAJOR ABDOMINAL CDS, Model Number: CDS983908Q; 21) NHP ROBOTIC GENERAL CDS, Model Number: CDS984244I; 22) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431M; 23) MAJOR ABDOMINAL CDS (NO GOWNS), Model Number: CDS985557L; 24) PREP KIT, Model Number: DYK1022113CP; 25) BARRIER KIT,UNIV OF ALABAMA, Model Number: DYK1060193B; 26) PERSONAL ITEM KIT, Model Number: DYKA1131; 27) GI PACK, Model Number: DYKE1441D; 28) GI PACK, Model Number: DYKE1441G; 29) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456C; 30) VIDEO BRONCHOSCOPY TRAY, Model Number: DYKE1666; 31) GI LAB OTHER ENDO KIT, Model Number: DYKE1721A; 32) MATERNITY KIT, Model Number: DYKL1343; 33) BUNNY KIT, Model Number: DYKM1054C; 34) ASST STERILE PPE, Model Number: DYKM1270; 35) MASK CAP AND GOWN KIT, Model Number: DYKM1427A; 36) BLOOD PRECAUTION KIT, Model Number: DYKM1687; 37) HELPERS KIT, Model Number: DYKM1832; 38) BRONCHOSPY SUPPLY KIT, Model Number: DYKM1898; 39) OP UROLOGY KIT, Model Number: DYKM2316; 40) ICU PACK, Model Number: DYKM2671; 41) KIT OMF LEFORTE, Model Number: DYKMBNDL1; 42) KIT GEN SURG RECTAL, Model Number: DYKMBNDL103; 43) KIT GEN SURG RECTAL, Model Number: DYKMBNDL103A; 44) KIT GEN SURG RECTAL, Model Number: DYKMBNDL103B; 45) KIT UROLOGY EXPLORATORY, Model Number: DYKMBNDL115; 46) KIT UROLOGY EXPLORATORY, Model Number: DYKMBNDL115A; 47) KIT UROLOGY EXPLORATORY, Model Number: DYKMBNDL115B; 48) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116C; 49) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117B; 50) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121D; 51) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121G; 52) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121I; 53) KIT ACES INSERT PEG, Model Number: DYKMBNDL130B; 54) KIT OMF PEDS MINOR, Model Number: DYKMBNDL139; 55) KIT THOR ESOPH PERF.REPAIR, Model Number: DYKMBNDL140; 56) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142A; 57) KIT OMF TMJ ARTHROPLASTY (OPEN, Model Number: DYKMBNDL146A; 58) KIT OMF TMJ ARTHROPLASTY (OPEN, Model Number: DYKMBNDL146C; 59) KIT OMF TMJ ARTHROPLASTY (OPEN, Model Number: DYKMBNDL146D; 60) KIT THORACIC THYMECTOMY, Model Number: DYKMBNDL161; 61) KIT ORTHO TOTAL SHOULDER, Model Number: DYKMBNDL162B; 62) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165B; 63) KIT OMF MINOR, Model Number: DYKMBNDL166; 64) KIT TRANSPLANT PARTIAL LIVER, Model Number: DYKMBNDL167; 65) KIT TRANSPLANT PARTIAL LIVER, Model Number: DYKMBNDL167A; 66) KIT TRANSPLANT LIVER EX-LAP, Model Number: DYKMBNDL167B; 67) KIT LAP DONOR NEPHRECTOMY, Model

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98329
Lot/product code:
1) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 22HDA973; 2) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 22BDB172; 3) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 21LDA438; 4) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 21CDB692; 5) ACC010326, UDI-DI: 10889942735525(each), 40889942735526(case), Lot Number: 21CDB175; 6) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 24GDA256; 7) ACC010326A, UDI-DI: 10195327347147(each), 40195327347148(case), Lot Number: 23IDB293; 8) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 23EDC028; 9) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 23EDB192; 10) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 23EDA657; 11) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 22LDA361; 12) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 22KDB086; 13) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 22JDB707; 14) ACC010475, UDI-DI: 10193489469011(each), 40193489469012(case), Lot Number: 21BDA319; 15) ACC010542, UDI-DI: 10193489997279(each), 40193489997270(case), Lot Number: 24DDA266; 16) ACC010542, UDI-DI: 10193489997279(each), 40193489997270(case), Lot Number: 23JDA838; 17) ACC010542, UDI-DI: 10193489997279(each), 40193489997270(case), Lot Number: 22FDB178; 18) ACC010542, UDI-DI: 10193489997279(each), 40193489997270(case), Lot Number: 22DDB648; 19) ACC010542, UDI-DI: 10193489997279(each), 40193489997270(case), Lot Number: 21KDA051; 20) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 25KDB023; 21) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 25JDB588; 22) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 23JDB732; 23) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 23CDB042; 24) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 22EDA459; 25) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 22CDA899; 26) ACC010543, UDI-DI: 10193489997286(each), 40193489997287(case), Lot Number: 21KDB787; 27) ACC010722, UDI-DI: 10195327472412(each), 40195327472413(case), Lot Number: 23JDC381; 28) ACC010722, UDI-DI: 10195327472412(each), 40195327472413(case), Lot Number: 23JDB244; 29) ACC010896, UDI-DI: 10198459166815(each), 40198459166816(case), Lot Number: 24LDA583; 30) CDS860063U, UDI-DI: 10195327148638(each), 40195327148639(case), Lot Number: 23LBO008; 31) CDS860066T, UDI-DI: 10195327107741(each), 40195327107742(case), Lot Number: 23LBK545; 32) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 24GBK408; 33) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 24BBL254; 34) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 23JBS427; 35) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 23EBW445; 36) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 23EBH164; 37) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 23CBG007; 38) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 23ABD835; 39) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 22KBV668; 40) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 22JBH118; 41) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 22HBM408; 42) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 22DBF114; 43) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 21LBE721; 44) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 21IBP643; 45) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 21FBT373; 46) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 21DBC918; 47) CDS981795G, UDI-DI: 10889942913640(each), 40889942913641(case), Lot Number: 21BBE784; 48) CDS982414N, UDI-DI: 10193489847284(each), 40193489847285(case), Lot Number: 22OBM444; 49) CDS982414N, UDI-DI: 10193489847284(each), 40193489847285(case), Lot Number: 22GBH219; 50) CDS982414N, UDI-DI: 10193489847284(each), 40193489847285(case), Lot Number: 22BBB915; 51) CDS982414N, UDI-DI: 10193489847284(each), 40193489847285(case), Lot Number: 21IBL978; 52) CDS982414N, UDI-DI: 10193489847284(each), 40193489847285(case), Lot Number: 21GBE905; 53) CDS982414N, UDI-DI: 10193489847284(each), 40193489847285(case), Lot Number: 21FBG328; 54) CDS982414N, UDI-DI: 10193489847284(each), 40193489847285(case), Lot Number: 21DBU729; 55) CDS982823R, UDI-DI: 10195327584481(each), 40195327584482(case), Lot Number: 24CBI679; 56) CDS982823R, UDI-DI: 10195327584481(each), 40195327584482(case), Lot Number: 24BBG7… (truncated, 176026 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501G; 3) ARTHROSCOPY PACK, Model Number: DYNJ32715F; 4) CHS ARTHROSCOPY PACK, Model Number: DYNJ50834C; 5) ARTHROSCOPY TRAY-LF, Model Number: DYNJ51069

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

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FDA has not published a risk classification for this recall yet.

Recall #:
98329
Lot/product code:
1) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 23BBL738; 2) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 23BBJ847; 3) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 22IBF936; 4) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 22IBE795; 5) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 22FBP788; 6) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 22BBD031; 7) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 22ABJ831; 8) CDS984609B, UDI-DI: 10889942719372(each), 40889942719373(case), Lot Number: 21JBJ732; 9) DYNJ22501G, UDI-DI: 10889942234110(each), 40889942234111(case), Lot Number: 21CBZ902; 10) DYNJ22501G, UDI-DI: 10889942234110(each), 40889942234111(case), Lot Number: 21ABK153; 11) DYNJ32715F, UDI-DI: 10889942530038(each), 40889942530039(case), Lot Number: 21ADB529; 12) DYNJ50834C, UDI-DI: 10889942568178(each), 40889942568179(case), Lot Number: 21BDA710; 13) DYNJ51069, UDI-DI: 10889942118410(each), 40889942118411(case), Lot Number: 21BDB116
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Brilliance iCT; Product Code (REF): 728306;

As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

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FDA has not published a risk classification for this recall yet.

Recall #:
98248
Lot/product code:
Product Code (REF): 728306; UDI-DI: 00884838059474; Serial Numbers: 87064, 87120, 87121, 87122, 87125, 87126, 87127, 87128, 87129, 87130, 87135, 87143, 87148, 87152, 87153, 87157, 87160, 87162, 87167, 87173, 87174, 87176, 87181, 87197, 87198, 87199, 87200 , 87202, 87203, 87204, 87205, 87206, 87207, 87208, 87209, 87210, 87211, 87212, 87213 , 87214, 87215, 87216, 87217, 87218, 87219, 87220, 87221;
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

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▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98642
Lot/product code:
1) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21BFA109; 2) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21EFA047; 3) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21FFA074; 4) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21GFA025; 5) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21HFA112; 6) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21IFA100; 7) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21JFA039; 8) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21JFA139; 9) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 21KFA114; 10) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22BFA066; 11) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22CFA086; 12) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22DFA081; 13) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22IFA036; 14) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22JFA111; 15) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 22LFA068; 16) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23AFA049; 17) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23AFA090; 18) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23BFA006; 19) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23BFA124; 20) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23CFA070; 21) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23DFA024; 22) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23EFA007; 23) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23EFA070; 24) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23GFA079; 25) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23HFA039; 26) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23HFA117; 27) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23HFA178; 28) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23IFA139; 29) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23JFA065; 30) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23KFA006; 31) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23KFA054; 32) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 23LFA050; 33) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24BFA115; 34) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24FFA115; 35) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24GFA027; 36) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24IFA085; 37) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24JFA035; 38) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24JFA136; 39) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 24KFA099; 40) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 25CFA033; 41) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 25DFA033; 42) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 25FFA025; 43) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 25GFA099; 44) DYK1011945P, UDI-DI: 10884389389973(each), 40884389389974(case), Lot Number: 25IFA006
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Devices which did not undergo thermoforming could deform and lose performance.

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FDA has not published a risk classification for this recall yet.

Recall #:
98252
Lot/product code:
Model/Catalog Number: KD-401Q-0725; Material REF: 5856930; UDI-DI: 04953170041587; All Lots with a valid expiration date
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Devices which did not undergo thermoforming could deform and lose performance.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98252
Lot/product code:
Model/Catalog Number: KD-V411M-0730; Material REF: (1) N1089810, (2) N5411530; UDI-DI: (1) 04953170380594, (2) 04953170380594; All Lots with a valid expiration date
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268B; 3) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268C; 4) TRAY 6 CENTRAL LINE A, Model Number: ACC010487; 5) PEDS PICC INSERTION TRAY, Model Number: CVI3650; 6) LINE ATTIRE KIT, Model Number: DYKM2170; 7) KIT SURG ONC LAP DIAG/PORT INS, Model Number: DYKMBNDL153C; 8) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43A; 9) KIT SURG ONC PORT INSERTION, Model Number: DYKMBNDL43C; 10) VEIN PROCEDURE KIT, Model Number: DYNDA2076B; 11) VEIN PROCEDURE KIT, Model Number: DYNDA2076D; 12) VEIN PROCEDURE KIT, Model Number: DYNDA2076F; 13) PLACENTA KIT, Model Number: DYNDA2322B; 14) NICU CENTRAL LINE TRAY, Model Number: DYNDC2407A; 15) NICU CENTRAL LINE TRAY, Model Number: DYNDC2407B; 16) PICC LINE TRAY, Model Number: DYNJ40500A; 17) VENOUS ACCESS PACK, Model Number: DYNJ42694C; 18) AV FISTULA CREATION PACK-LF, Model Number: DYNJ53427B; 19) PICC LINE, Model Number: DYNJ55546D; 20) PICC TRAY, Model Number: DYNJ63199A; 21) PICC KIT 4F SL PL MAX BARRIER, Model Number: DYNJ70141MB; 22) PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB; 23) VEIN PACK, Model Number: DYNJ84239; 24) PICC INSERTION TRAY W/O CATH, Model Number: PICCNC0004

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98329
Lot/product code:
1) 00-401993O, UDI-DI: 10195327517366(each), 40195327517367(case), Lot Number: 23KBH528; 2) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 24DDA188; 3) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23IDA297; 4) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23GDB567; 5) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23FDC048; 6) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23DDB175; 7) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23DDA455; 8) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23BDB271; 9) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22FDB218; 10) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22DDA763; 11) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22CDC433; 12) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22BDA862; 13) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22ADC105; 14) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21JDB458; 15) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21IDC222; 16) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21CDB078; 17) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21BDB379; 18) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24KDA478; 19) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24JDB298; 20) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24IDB060; 21) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24HDB961; 22) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23HDA348; 23) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDB680; 24) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDB672; 25) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDA369; 26) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23FDB587; 27) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23EDB085; 28) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 22BDB354; 29) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 21LDB744; 30) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 21CDC422; 31) CVI3650, UDI-DI: 10653160256397(each), 40653160256398(case), Lot Number: 22EBO541; 32) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 23BBA792; 33) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 23ABC583; 34) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 22IBN124; 35) DYKMBNDL153C, UDI-DI: 10198459000430(each), 40198459000431(case), Lot Number: 24DBR907; 36) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 23BBS866; 37) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 23ABK335; 38) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 22IBM493; 39) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 22IBK412; 40) DYKMBNDL43C, UDI-DI: 10198459000553(each), 40198459000554(case), Lot Number: 24DBS686; 41) DYNDA2076B, UDI-DI: 10195327572020(each), 40195327572021(case), Lot Number: 24ABI534; 42) DYNDA2076D, UDI-DI: 10198459216060(each), 40198459216061(case), Lot Number: 24LMH364; 43) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25KMH542; 44) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25IMA505; 45) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25HMH651; 46) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25FMF582; 47) DYNDA2322B, UDI-DI: 10195327299774(each), 40195327299775(case), Lot Number: 23FBW064; 48) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 22FME865; 49) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21OBA058; 50) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21LBT037; 51) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21JBV496; 52) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21DBA072; 53) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21ABI600; 54) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 25IMA418; 55) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 25FMG170; 56) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lo… (truncated, 7629 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBNDL106A; 3) KIT UROLOGY PENILE REPAIR, Model Number: DYKMBNDL188; 4) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189; 5) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189A

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98329
Lot/product code:
1) DYKMBNDL106, UDI-DI: 10193489479294(each), 40193489479295(case), Lot Number: 21BBG085; 2) DYKMBNDL106, UDI-DI: 10193489479294(each), 40193489479295(case), Lot Number: 21ABJ542; 3) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 22CLA049; 4) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 22BLB059; 5) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 22ALA713; 6) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 21KLA631; 7) DYKMBNDL188, UDI-DI: 10193489478549(each), 40193489478540(case), Lot Number: 21CBS043; 8) DYKMBNDL188, UDI-DI: 10193489478549(each), 40193489478540(case), Lot Number: 21ABS540; 9) DYKMBNDL188, UDI-DI: 10193489478549(each), 40193489478540(case), Lot Number: 21ABS539; 10) DYKMBNDL189, UDI-DI: 10193489478457(each), 40193489478458(case), Lot Number: 21BBG092; 11) DYKMBNDL189, UDI-DI: 10193489478457(each), 40193489478458(case), Lot Number: 21ABI996; 12) DYKMBNDL189A, UDI-DI: 10193489880823(each), 40193489880824(case), Lot Number: 21JLA521
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977C; 3) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 4) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 5) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4; 6) NICU LINE CHANGE TRAY, Model Number: LC295

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98642
Lot/product code:
1) CVI4300, UDI-DI: 10653160294313(each), 653160294316(case), Lot Number: 2020120950; 2) DYKM1977C, UDI-DI: 10653160381105(each), 653160381108(case), Lot Number: 2024110190; 3) DYKMBNDL130, UDI-DI: 10193489479027(each), 40193489479028(case), Lot Number: 21ABC197; 4) DYKMBNDL130, UDI-DI: 10193489479027(each), 40193489479028(case), Lot Number: 21ABJ543; 5) DYKMBNDL130, UDI-DI: 10193489479027(each), 40193489479028(case), Lot Number: 21BBB580; 6) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21CLA391; 7) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21CLA391Z; 8) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21CLA621; 9) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21DLA326; 10) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21ELA080; 11) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21FLA214; 12) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21GLA677; 13) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21HLA740; 14) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21ILA163; 15) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21JLA910; 16) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22ALA593; 17) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22BLA721; 18) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22CLA448; 19) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22DLA407; 20) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22ELA008; 21) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22FLA745; 22) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22GLA694; 23) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22GLB021; 24) DYKMBNDL4, UDI-DI: 10193489477627(each), 40193489477628(case), Lot Number: 21ALA056; 25) DYKMBNDL4, UDI-DI: 10193489477627(each), 40193489477628(case), Lot Number: 21ALA631; 26) DYKMBNDL4, UDI-DI: 10193489477627(each), 40193489477628(case), Lot Number: 21DLA343; 27) LC295, UDI-DI: 10653160322702(each), 653160322705(case), Lot Number: 2025110490
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98329
Lot/product code:
1) DYNDM1031A, UDI-DI: 10884389555897(each), 40884389555898(case), Lot Number: 23EBM150
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) BREAST-HERNIA-PORT CDS-LF, Model Number: CDS984853J; 3) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 4) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158; 5) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170; 6) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170A; 7) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170B; 8) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182;

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98642
Lot/product code:
1) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21DDA661; 2) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21FDA888; 3) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21GDB740; 4) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21HDB434; 5) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21JDB530; 6) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 23HDB786; 7) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 23IDB182; 8) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 23LDC086; 9) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 24IDA403; 10) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 24JDA650; 11) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 25ADB705; 12) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 25BDA228; 13) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 25BDB702; 14) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 25FDA013; 15) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 25GDB671; 16) CDS984853J, UDI-DI: 10195327694180(each), 40195327694181(case), Lot Number: 24DDC169; 17) CDS984853J, UDI-DI: 10195327694180(each), 40195327694181(case), Lot Number: 24EDA131; 18) DYKMBNDL117C, UDI-DI: 10195327371104(each), 40195327371105(case), Lot Number: 23DLA834; 19) DYKMBNDL158, UDI-DI: 10193489478266(each), 40193489478267(case), Lot Number: 21ABI978; 20) DYKMBNDL158, UDI-DI: 10193489478266(each), 40193489478267(case), Lot Number: 21CBE548; 21) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 20LBY951; 22) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21ABJ202; 23) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21BBH637; 24) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21DBN049; 25) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21IBV640; 26) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 22EBA143; 27) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 22HBN456; 28) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 22IBC515; 29) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 22JBM366; 30) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23GBR888; 31) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23HBB877; 32) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23HBG507; 33) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23IBB851; 34) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 24FBD539; 35) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 24FBL546; 36) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 24IBB931; 37) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25BBA340; 38) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25BBN216; 39) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25DBK034; 40) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25DBS731; 41) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25EBM448; 42) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25GBA895; 43) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25HBP137; 44) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25KBR870; 45) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25LBM160; 46) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 21ABI990; 47) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 21ABX025; 48) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 21DBC569; 49) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 22BBN306; 50) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 22EBO665; 51) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 22FBC879; 52) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 23LBI220; 53) DYKMBNDL182A, UDI-DI: 10195327633806(each), 40195327633807(case), Lot Number: 24BBN507; 54) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24DBR913; 55) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24IBL678; 56) DYKMBNDL182… (truncated, 25220 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W; 4) MAJOR LAPAROTOMY CDS, Model Number: CDS860015X; 5) MINOR LAPAROTOMY CDS, Model Number: CDS860016P; 6) MINOR LAPAROTOMY CDS, Model Number: CDS860016Q; 7) MINOR LAPAROTOMY CDS, Model Number: CDS860016R; 8) MINOR LAPAROTOMY CDS, Model Number: CDS860016S; 9) LAP GASTRIC BYPASS CDS, Model Number: CDS860146M;

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98642
Lot/product code:
1) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21FBR386; 2) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21GBS688; 3) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21IBL031; 4) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21KBB595; 5) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21LBD726; 6) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21LBT172; 7) CDS860015V, UDI-DI: 10195327209582(each), 40195327209583(case), Lot Number: 22HBF170; 8) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23FBP597; 9) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23GBM065; 10) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23HBT489; 11) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23JBR469; 12) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23KBX194; 13) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23LBQ388; 14) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 24DBC504; 15) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 24DBP400; 16) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 24EBA340; 17) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 25DBF532; 18) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 25EBQ940; 19) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21EBD212; 20) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21FBC634; 21) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21GBV761; 22) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21GBV762; 23) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21KBI389; 24) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 22ABD367; 25) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 22BBL530; 26) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 22FBH684; 27) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 22FBQ637; 28) CDS860016Q, UDI-DI: 10195327209599(each), 40195327209590(case), Lot Number: 22JBE511; 29) CDS860016Q, UDI-DI: 10195327209599(each), 40195327209590(case), Lot Number: 22KBA835; 30) CDS860016Q, UDI-DI: 10195327209599(each), 40195327209590(case), Lot Number: 23ABM653; 31) CDS860016R, UDI-DI: 10195327349479(each), 40195327349470(case), Lot Number: 23GBD634; 32) CDS860016R, UDI-DI: 10195327349479(each), 40195327349470(case), Lot Number: 23IBO655; 33) CDS860016R, UDI-DI: 10195327349479(each), 40195327349470(case), Lot Number: 23KBP519; 34) CDS860016R, UDI-DI: 10195327349479(each), 40195327349470(case), Lot Number: 24BBK121; 35) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24CBD741; 36) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24DBJ711; 37) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24GBQ718; 38) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24HBG876; 39) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24KBA566; 40) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24LBS320; 41) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 25DBK311; 42) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 25FBG578; 43) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 25JBA926; 44) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 25LMH226; 45) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 23ABM631; 46) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 23EBP265; 47) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 23GBA234; 48) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 23HBI319; 49) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 23HBI540; 50) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 23IBF963; 51) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 23JBF435; 52) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 23JBU728; 53) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 23LBU990; 54) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 24CBJ982; 55) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 24DBD791; 56) CDS860146M, UDI-DI: 10195327224547(each), 4019532722454… (truncated, 171864 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Devices which did not undergo thermoforming could deform and lose performance.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98252
Lot/product code:
Model/Catalog Number: KD-V431M-0730; Material REF: (1) N1090530, (2) N1090510, (3) N5412030; UDI-DI: (1) 04953170380648, (2) 04953170380648, (3) 04953170380648; All Lots with a valid expiration date
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431J; 4) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 5) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431L; 6) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431N; 7) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O; 8) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A; 9) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116A; 10) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116G; 11) ROBOTIC PACK, Model Number: DYNJ04135B; 12) MINOR LITHOTOMY PACK, Model Number: DYNJ04382J; 13) NBMC D & C PACK-LF, Model Number: DYNJ0665843C; 14) D&C PACK-LF, Model Number: DYNJ22567G; 15) D&C PACK-LF, Model Number: DYNJ22567I; 16) D&C PACK-LF, Model Number: DYNJ22567J; 17) D&C PACK-LF, Model Number: DYNJ22567K; 18) D&C HYSTEROSCOPY PACK, Model Number: DYNJ38805B; 19) D AND C, Model Number: DYNJ41272B; 20) D AND C, Model Number: DYNJ41272C; 21) OB PACK, Model Number: DYNJ42884; 22) D&C/GYN PACK, Model Number: DYNJ47713A; 23) PERI GYN PACK, Model Number: DYNJ55377D; 24) ANTERIOR CERVICAL-LF, Model Number: DYNJ58344; 25) D&C PACK, Model Number: DYNJ67214D; 26) D&C PACK, Model Number: DYNJ67214F; 27) D&C PACK, Model Number: DYNJ67214G; 28) D&C PACK, Model Number: DYNJ67214I; 29) LITHOTOMY PACK, Model Number: DYNJ80765C; 30) GYN PACK, Model Number: DYNJ83475; 31) D AND C PACK, Model Number: DYNJ87468; 32) D&C-ASC, Model Number: DYNJ900465C; 33) D&C-ASC, Model Number: DYNJ900465D; 34) D&C-ASC, Model Number: DYNJ900465F; 35) GYN LITHOTOMY-LF, Model Number: DYNJ902711L; 36) GYN LITHOTOMY-LF, Model Number: DYNJ902711N; 37) D&C, Model Number: DYNJ906947C; 38) PACK PERI GYN DSMC, Model Number: DYNJT6424

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

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FDA has not published a risk classification for this recall yet.

Recall #:
98642
Lot/product code:
1) CDS982407N, UDI-DI: 10193489683004(each), 40193489683005(case), Lot Number: 21CBD150; 2) CDS982407N, UDI-DI: 10193489683004(each), 40193489683005(case), Lot Number: 21DBO201; 3) CDS985431J, UDI-DI: 10195327336110(each), 40195327336111(case), Lot Number: 23BBG608; 4) CDS985431J, UDI-DI: 10195327336110(each), 40195327336111(case), Lot Number: 23DBM469; 5) CDS985431J, UDI-DI: 10195327336110(each), 40195327336111(case), Lot Number: 23FBA948; 6) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23GBL932; 7) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23GBM332; 8) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23IBQ647; 9) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23JBF512; 10) CDS985431L, UDI-DI: 10195327527273(each), 40195327527274(case), Lot Number: 24ABA205; 11) CDS985431L, UDI-DI: 10195327527273(each), 40195327527274(case), Lot Number: 24ABV349; 12) CDS985431L, UDI-DI: 10195327527273(each), 40195327527274(case), Lot Number: 24ABW239; 13) CDS985431L, UDI-DI: 10195327527273(each), 40195327527274(case), Lot Number: 24CBR704; 14) CDS985431L, UDI-DI: 10195327527273(each), 40195327527274(case), Lot Number: 24EBP485; 15) CDS985431N, UDI-DI: 10198459081590(each), 40198459081591(case), Lot Number: 24JBG321; 16) CDS985431O, UDI-DI: 10198459195006(each), 40198459195007(case), Lot Number: 24LBH099; 17) CDS985431O, UDI-DI: 10198459195006(each), 40198459195007(case), Lot Number: 25ABT899; 18) CDS985431O, UDI-DI: 10198459195006(each), 40198459195007(case), Lot Number: 25CBE670; 19) CDS985431O, UDI-DI: 10198459195006(each), 40198459195007(case), Lot Number: 25EBE265; 20) CDS985431O, UDI-DI: 10198459195006(each), 40198459195007(case), Lot Number: 25GBB847; 21) CDS985431O, UDI-DI: 10198459195006(each), 40198459195007(case), Lot Number: 25HBO500; 22) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21CBQ508; 23) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21DBC065; 24) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21FBB105; 25) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21GBE967; 26) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21IBS290; 27) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21DBE919; 28) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21FBB101; 29) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21HBB549; 30) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21KBQ697; 31) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22EBP060; 32) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22EBP063; 33) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22FBC878; 34) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22FBM235; 35) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22GBL821; 36) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22HBE127; 37) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 24KBD429; 38) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 24LBE008; 39) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 24LBH410; 40) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25ABF361; 41) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25BBI842; 42) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25EBM426; 43) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25GBG086; 44) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 20XBF598; 45) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23CBK988; 46) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23EBS948; 47) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23HBP307; 48) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23JBY840; 49) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23KBH005; 50) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23KBM003; 51) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23KBT507; 52) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23LBM979; 53) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 24GBG491; 54) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 24KBD673; 55) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 25BBP569; 56) DYNJ04135B,… (truncated, 18470 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104A; 3) KIT OPHTHALMOLOGY CORNEAL TRAN, Model Number: DYKMBNDL159; 4) KIT OPHTHALMOLOGY CATARACT, Model Number: DYKMBNDL180; 5) KIT OPHTHALMOLOGY EYE MUSCLE, Model Number: DYKMBNDL42; 6) KIT SURG ONC PORT INSERTION, Model Number: DYKMBNDL43B; 7) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84B; 8) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98; 9) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98A; 10) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98B; 11) CAROMONT EYE TRAY-LF, Model Number: DYNJ17004L; 12) MINOR EYE PACK, Model Number: DYNJ17219C; 13) PEDS EYE/MUSCLE PACK, Model Number: DYNJ38791M; 14) EYE PACK, Model Number: DYNJ41207C; 15) OPHTHALMIC PACK, Model Number: DYNJ42043I; 16) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852J; 17) CUSTOM EYE PACK HA-LF, Model Number: DYNJ45585C; 18) EYE PLASTIC PACK, Model Number: DYNJ47859B; 19) EYE PLASTIC PACK, Model Number: DYNJ47859C; 20) CATARACT PACK, Model Number: DYNJ53019A; 21) CATARACT PACK, Model Number: DYNJ54869A; 22) VITRECTOMY PACK, Model Number: DYNJ55280B; 23) NDNW-EYE PACK, Model Number: DYNJ61779C; 24) EYE PK, Model Number: DYNJ62306; 25) VITRECTOMY, Model Number: DYNJ64220; 26) OSC BREAST PACK, Model Number: DYNJ65808C; 27) MILLS CATARACT PACK, Model Number: DYNJ67973A; 28) EYE PACK, Model Number: DYNJ68367B; 29) CATARACT PACK, Model Number: DYNJ68875D; 30) CATARACT PACK, Model Number: DYNJ68875F; 31) CATARACT PACK, Model Number: DYNJ68875G; 32) VITRECTOMY IP, Model Number: DYNJ84020; 33) PLASTIC PACK, Model Number: DYNJ86288; 34) OPHTHO PLASTIC, Model Number: DYNJ902256C; 35) RETINAL, Model Number: DYNJ907495; 36) CATARACT, Model Number: DYNJ909924; 37) CATARACT, Model Number: DYNJ909924A; 38) COMBO EYE, Model Number: DYNJ909925; 39) VITRECTOMY, Model Number: DYNJ909929; 40) RETINAL PK-LF, Model Number: DYNJC2364O

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98642
Lot/product code:
1) DYKMBNDL104, UDI-DI: 10193489478945(each), 40193489478946(case), Lot Number: 21ABV400; 2) DYKMBNDL104, UDI-DI: 10193489478945(each), 40193489478946(case), Lot Number: 21FBP706; 3) DYKMBNDL104, UDI-DI: 10193489478945(each), 40193489478946(case), Lot Number: 21IBV636; 4) DYKMBNDL104, UDI-DI: 10193489478945(each), 40193489478946(case), Lot Number: 22GBP895; 5) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 22HBX475; 6) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 22JBS899; 7) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 22JBS907; 8) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 22KBO773; 9) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 23HBV380; 10) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 24EBU650; 11) DYKMBNDL104A, UDI-DI: 10195327240622(each), 40195327240623(case), Lot Number: 25HBK503; 12) DYKMBNDL159, UDI-DI: 10193489478273(each), 40193489478274(case), Lot Number: 21ABQ655; 13) DYKMBNDL180, UDI-DI: 10193489478464(each), 40193489478465(case), Lot Number: 21ABT655; 14) DYKMBNDL180, UDI-DI: 10193489478464(each), 40193489478465(case), Lot Number: 21BBM375; 15) DYKMBNDL180, UDI-DI: 10193489478464(each), 40193489478465(case), Lot Number: 21FBP773; 16) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21ABR620; 17) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21BBK655; 18) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21FLA394; 19) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21HLA179; 20) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21ILA655; 21) DYKMBNDL42, UDI-DI: 10193489478884(each), 40193489478885(case), Lot Number: 21KLA277; 22) DYKMBNDL43B, UDI-DI: 10195327369200(each), 40195327369201(case), Lot Number: 23CBP086; 23) DYKMBNDL43B, UDI-DI: 10195327369200(each), 40195327369201(case), Lot Number: 23DBD264; 24) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23CBP088; 25) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23EBL613; 26) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23FBU438; 27) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23GBE628; 28) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23IBA614; 29) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23JBK353; 30) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23KBJ008; 31) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 23LBI221; 32) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24ABH891; 33) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24BBJ841; 34) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24CBA180; 35) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24EBF870; 36) DYKMBNDL84B, UDI-DI: 10195327369026(each), 40195327369027(case), Lot Number: 24HBS367; 37) DYKMBNDL98, UDI-DI: 10193489477931(each), 40193489477932(case), Lot Number: 21ABT657; 38) DYKMBNDL98, UDI-DI: 10193489477931(each), 40193489477932(case), Lot Number: 21DBC009; 39) DYKMBNDL98, UDI-DI: 10193489477931(each), 40193489477932(case), Lot Number: 21GBJ364; 40) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 21IBP918; 41) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22BBW517; 42) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22BBW535; 43) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22FBB999; 44) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22GBW969; 45) DYKMBNDL98A, UDI-DI: 10193489975482(each), 40193489975483(case), Lot Number: 22OBC233; 46) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 22JBC619; 47) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 22JBT177; 48) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 22KBA356; 49) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 22KBD243; 50) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 24FBB728; 51) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 25BBJ362; 52) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 25BBU487; 53) DYKMBNDL98B, UDI-DI: 10195327241223(each), 40195327241224(case), Lot Number: 25EBG033; 54) DYNJ17004L, UDI-DI: 10193489244144(each), 40193489244145(case), Lot Number: 23JBA703; 55) DYNJ17219C, UDI-DI: 10888277053007(each), 40888277053008(case), Lot Number: 21ADA445; 56) DYNJ… (truncated, 12399 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98329
Lot/product code:
1) DYKE1455B, UDI-DI: 10193489760781(each), 40193489760782(case), Lot Number: 22IBV801; 2) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23KMC417; 3) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23IMF495; 4) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23HMG566; 5) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23GMF416; 6) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23GMC067; 7) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23EMF635; 8) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23CMG332; 9) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23CMC558; 10) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23CMB706; 11) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23BMC768; 12) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22LMF786; 13) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22JMC784; 14) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22HMD809; 15) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22GMH729; 16) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22FMH954; 17) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22FMD365; 18) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22EMI534; 19) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22EMH737; 20) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 21KBP287; 21) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 21IBL687; 22) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 21CBH946; 23) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 21CBH534; 24) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 21BBK795
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 3) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158; 4) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170; 5) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170A; 6) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170B; 7) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182; 8) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182A; 9) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182B; 10) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183; 11) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183A; 12) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183B; 13) KIT STC FACIAL FRACTURE, Model Number: DYKMBNDL34A; 14) KIT SURG ONC MASTECTOMY A, Model Number: DYKMBNDL39; 15) KIT SURG ONC MASTECTOMY A, Model Number: DYKMBNDL39A; 16) KIT SURG ONC MASTECTOMY, Model Number: DYKMBNDL39C; 17) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL46; 18) KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54; 19) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69; 20) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69A; 21) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69B; 22) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78; 23) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78A; 24) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78B; 25) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84; 26) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84C; 27) MJR PLASTICS PK MV SURG CT-LF, Model Number: DYNJ0785310G; 28) ASC ENT PLASTIC PACK-LF, Model Number: DYNJ0854650J; 29) BREAST PACK ASC-LF, Model Number: DYNJ36469I; 30) ENT TYMPANOPLASTY PACK-LF, Model Number: DYNJ38988J; 31) DR WILDE BRSTMASS/PARTMAST-XM, Model Number: DYNJ39831F; 32) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852K; 33) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852M; 34) BREAST PACK, Model Number: DYNJ50957G; 35) PLASTICS BREAST PACK, Model Number: DYNJ55358G; 36) BHN IMPLANT PACK, Model Number: DYNJ56737A; 37) BREAST PACK, Model Number: DYNJ60210A; 38) PLASTICS PACK 2, Model Number: DYNJ64927F; 39) SPECIALTY FACIAL PLASTICS PACK, Model Number: DYNJ68844A; 40) BREAST IMPLANT PACK, Model Number: DYNJ69351; 41) BREAST/TUMMY PACK, Model Number: DYNJ83788; 42) HMSL PLASTICS, Model Number: DYNJ83884B; 43) CHEST/BREAST-LF, Model Number: DYNJ83950A; 44) CHEST/BREAST-LF, Model Number: DYNJ83950B; 45) FREE FLAP A DIRTY, Model Number: DYNJ86165; 46) MAJOR SURGERY PACK, Model Number: DYNJ86816; 47) BREAST REDUCTION PACK, Model Number: DYNJ87444; 48) OMF FREE FLAP, Model Number: DYNJ902005I; 49) BREAST CDS, Model Number: DYNJ902558G; 50) TRUNCAL CONTOURING, Model Number: DYNJ903555D; 51) TRUNCAL CONTOURING, Model Number: DYNJ903555F; 52) NEW TISSUE RETRIEVAL MH, Model Number: DYNJ903849C; 53) LARGE PROCEDURE-LF, Model Number: DYNJ907847A; 54) (34) STC FACIAL FRACTURE, Model Number: DYNJ907874A; 55) FACELIFT, Model Number: DYNJ910462; 56) MAJOR PLASTIC BREAST PACK-LF, Model Number: DYNJT3283; 57) MAJOR BREAST PACK-LF, Model Number: DYNJT3417; 58) PLASTICS PACK-LF, Model Number: PHS806973G

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

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FDA has not published a risk classification for this recall yet.

Recall #:
98329
Lot/product code:
1) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 25BDB702; 2) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 25BDA228; 3) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 25ADB705; 4) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 24JDA650; 5) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 24IDA403; 6) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 23LDC086; 7) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 23IDB182; 8) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 23HDB786; 9) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21JDB530; 10) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21HDB434; 11) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21GDB740; 12) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21FDA888; 13) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21DDA661; 14) DYKMBNDL117C, UDI-DI: 10195327371104(each), 40195327371105(case), Lot Number: 23DLA834; 15) DYKMBNDL158, UDI-DI: 10193489478266(each), 40193489478267(case), Lot Number: 21CBE548; 16) DYKMBNDL158, UDI-DI: 10193489478266(each), 40193489478267(case), Lot Number: 21ABI978; 17) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 22IBC515; 18) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 22HBN456; 19) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 22EBA143; 20) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21IBV640; 21) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21DBN049; 22) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21BBH637; 23) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21ABJ202; 24) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 20LBY951; 25) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23IBB851; 26) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23HBG507; 27) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23HBB877; 28) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23GBR888; 29) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 22JBM366; 30) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25LBM160; 31) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25KBR870; 32) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25GBA895; 33) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25EBM448; 34) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25DBS731; 35) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25DBK034; 36) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25BBN216; 37) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25BBA340; 38) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 24IBB931; 39) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 24FBL546; 40) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 24FBD539; 41) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 23LBI220; 42) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 22FBC879; 43) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 22EBO665; 44) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 22BBN306; 45) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 21DBC569; 46) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 21ABX025; 47) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 21ABI990; 48) DYKMBNDL182A, UDI-DI: 10195327633806(each), 40195327633807(case), Lot Number: 24BBN507; 49) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 25FBO935; 50) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 25ABL533; 51) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24KBS891; 52) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24IBQ469; 53) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24IBL678; 54) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24DBR913; 55) DYKMBNDL183, UDI-DI: 10193489478495(each), 40193489478496(case), Lot Number: 21JBJ252; 56) DY… (truncated, 22846 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98642
Lot/product code:
1) DYNJ50806L, UDI-DI: 10195327344672(each), 40195327344673(case), Lot Number: 23FBK937
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

ALL 50 STATES
▸Full report

FDA has not published a risk classification for this recall yet.

Recall #:
98642
Lot/product code:
1) DYKE1455B, UDI-DI: 10193489760781(each), 40193489760782(case), Lot Number: 22IBV801; 2) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 21BBK795; 3) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 21CBH534; 4) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 21CBH946; 5) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 21IBL687; 6) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 21KBP287; 7) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22EMH737; 8) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22EMI534; 9) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22FMD365; 10) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22FMH954; 11) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22GMH729; 12) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22HMD809; 13) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22JMC784; 14) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 22LMF786; 15) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23BMC768; 16) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23CMB706; 17) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23CMC558; 18) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23CMG332; 19) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23EMF635; 20) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23GMC067; 21) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23GMF416; 22) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23HMG566; 23) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23IMF495; 24) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23KMC417
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)