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Recalls affecting Hawaii

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

16,254 recalls found
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Just announced

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.

View FDA’s announcement (opens in a new tab)
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.

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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

Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CS, Model Number: DYNJP8401

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) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525030011; 2) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525050004; 3) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525100025; 4) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525100068; 5) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525020012; 6) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525040038; 7) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525060015; 8) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525060041; 9) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525080004; 10) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525080039; 11) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72519120082; 12) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72519120084; 13) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72519120097; 14) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520020055; 15) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520030039; 16) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520030064; 17) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520030074; 18) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520050047; 19) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520060018; 20) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520060019; 21) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520070016; 22) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520080003; 23) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520080004; 24) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520080059; 25) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520100068; 26) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520120003; 27) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520120004; 28) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521040001; 29) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521050060; 30) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521050064; 31) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521050167; 32) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521060070; 33) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521070019; 34) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521070099; 35) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521080017; 36) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521090001; 37) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521090015; 38) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521100005; 39) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521100033; 40) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521110009; 41) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521110016; 42) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521120009; 43) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521120031; 44) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522010013; 45) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522020010; 46) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522030020; 47) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522040019; 48) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522050012; 49) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522050015; 50) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522060019; 51) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522060052; 52) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522070003; 53) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522080008; 54) DYNJP1050UG, UDI-DI: 10… (truncated, 7319 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) 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) PK BNDL CENT LINE PROTECT KIT, Model Number:DYKM2274; 8) KIT SURG ONC LAP DIAG/PORT INS, Model Number:DYKMBNDL153C; 9) KIT SURG ONC INSERT CENT.VENOU, Model Number:DYKMBNDL43A; 10) KIT SURG ONC PORT INSERTION, Model Number:DYKMBNDL43C; 11) VEIN PROCEDURE KIT, Model Number:DYNDA2076B; 12) VEIN PROCEDURE KIT, Model Number:DYNDA2076D; 13) VEIN PROCEDURE KIT, Model Number:DYNDA2076F; 14) PLACENTA KIT, Model Number:DYNDA2322B; 15) NICU CENTRAL LINE TRAY, Model Number:DYNDC2407A; 16) NICU CENTRAL LINE TRAY, Model Number:DYNDC2407B; 17) PICC LINE TRAY, Model Number:DYNJ40500A; 18) VENOUS ACCESS PACK, Model Number:DYNJ42694C; 19) AV FISTULA CREATION PACK-LF, Model Number:DYNJ53427B; 20) PICC LINE, Model Number:DYNJ55546D; 21) PICC TRAY, Model Number:DYNJ63199A; 22) PICC KIT 4F SL PL MAX BARRIER, Model Number:DYNJ70141MB; 23) PICC KIT 5F DL PL MB, Model Number:DYNJ70152MB; 24) VEIN PACK, Model Number:DYNJ84239; 25) NEXTON PACK, Model Number:DYNJ88152; 26) 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 #:
98642
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: 21BDB379; 3) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21CDB078; 4) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21IDC222; 5) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21JDB458; 6) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22ADC105; 7) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22BDA862; 8) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22CDC433; 9) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22DDA763; 10) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22FDB218; 11) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23BDB271; 12) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23DDA455; 13) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23DDB175; 14) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23FDC048; 15) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23GDB567; 16) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23IDA297; 17) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 24DDA188; 18) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24HDB961; 19) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24IDB060; 20) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24JDB298; 21) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24KDA478; 22) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 25DDB786; 23) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 25EDA196; 24) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 21CDC422; 25) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 21LDB744; 26) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 22BDB354; 27) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23EDB085; 28) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23FDB587; 29) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDA369; 30) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDB672; 31) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDB680; 32) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23HDA348; 33) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25ADB553; 34) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25BDA733; 35) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25BDB580; 36) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25HDA748; 37) CVI3650, UDI-DI: 10653160256397(each), 40653160256398(case), Lot Number: 22EBO541; 38) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 22IBN124; 39) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 23ABC583; 40) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 23BBA792; 41) DYKM2274, UDI-DI: 10198459278884(each), 40198459278885(case), Lot Number: 25HBK806; 42) DYKMBNDL153C, UDI-DI: 10198459000430(each), 40198459000431(case), Lot Number: 24DBR907; 43) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 22IBK412; 44) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 22IBM493; 45) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case).Lot Number: 23ABK335; 46) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 23BBS866; 47) DYKMBNDL43C, UDI-DI: 10198459000553(each), 40198459000554(case), Lot Number: 24DBS686; 48) DYNDA2076B, UDI-DI: 10195327572020(each), 40195327572021(case), Lot Number: 24ABI534; 49) DYNDA2076D, UDI-DI: 10198459216060(each), 40198459216061(case), Lot Number: 24LMH364; 50) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25FMF582; 51) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25HMH651; 52) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25IMA505; 53) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25KMH542; 54) DYNDA2322B, UDI-DI: 10195327299774(each), 40195327299775(case), Lot Number: 23FBW064; 55) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21ABI600; 56) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Numbe… (truncated, 8610 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) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model Number: GULLO SURGICAL PACK

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) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 22JBH446; 2) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23ABA768; 3) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23BBS986; 4) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23CBN951; 5) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23CBT510; 6) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23CBV199; 7) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23GBA134; 8) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23JBH393; 9) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24BBH600; 10) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24CMF059; 11) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24CMF059A; 12) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24EMC989; 13) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24HME376; 14) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24JMG165; 15) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24KMH629; 16) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 25AMD692; 17) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 25EMB013; 18) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 25FMI462; 19) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 25HMH340; 20) DYNJ87157, UDI-DI: 10198459014482(each), 40198459014483(case), Lot Number: 24ILA361
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) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number:DYNJ56436B; 3) SCC RF PAIN MGMT, Model Number:DYNJ56436C; 4) CPNB SETUP TRAY, Model Number:DYNJRA1979; 5) CPNB SETUP TRAY, Model Number:DYNJRA1979A; 6) CPNB SETUP TRAY, Model Number:DYNJRA1979B; 7) VARITHENA TRAY 2, Model Number:DYNJRA2608; 8) CPNB SETUP TRAY, Model Number:SAMPA0108

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) DYNJ56436A, UDI-DI: 10889942749874(each), 40889942749875(case), Lot Number: 21AMB799; 2) DYNJ56436A, UDI-DI: 10889942749874(each), 40889942749875(case), Lot Number: 21BMC737; 3) DYNJ56436B, UDI-DI: 10193489869569(each), 40193489869560(case), Lot Number: 21DME244; 4) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23AMG574; 5) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23DMA829; 6) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23DMI776; 7) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23EMH095; 8) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23FMI704; 9) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23HMC628; 10) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23IMC652; 11) DYNJRA1979, UDI-DI: 10195327186852(each), 40195327186853(case), Lot Number: 22GBV936; 12) DYNJRA1979, UDI-DI: 10195327186852(each), 40195327186853(case), Lot Number: 22IBU628; 13) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 24IMG516; 14) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 24JMA460; 15) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 24KMA261; 16) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 25DME153; 17) DYNJRA1979B, UDI-DI: 10198459371950(each), 40198459371951(case), Lot Number: 25FBG333; 18) DYNJRA2608, UDI-DI: 10198459331640(each), 40198459331641(case), Lot Number: 25ELB099; 19) SAMPA0108, UDI-DI: 10195327096861(each), 40195327096862(case), Lot Number: 22BBD381; 20) SAMPA0108, UDI-DI: 10195327096861(each), 40195327096862(case), Lot Number: 22NBG086
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 #:
98642
Lot/product code:
1) DYKMBNDL106, UDI-DI: 10193489479294(each), 40193489479295(case), Lot Number: 21ABJ542; 2) DYKMBNDL106, UDI-DI: 10193489479294(each), 40193489479295(case), Lot Number: 21BBG085; 3) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 21KLA631; 4) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 22ALA713; 5) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 22BLB059; 6) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 22CLA049; 7) DYKMBNDL188, UDI-DI: 10193489478549(each), 40193489478540(case), Lot Number: 21ABS539; 8) DYKMBNDL188, UDI-DI: 10193489478549(each), 40193489478540(case), Lot Number: 21ABS540; 9) DYKMBNDL188, UDI-DI: 10193489478549(each), 40193489478540(case), Lot Number: 21CBS043; 10) DYKMBNDL189, UDI-DI: 10193489478457(each), 40193489478458(case), Lot Number: 21ABI996; 11) DYKMBNDL189, UDI-DI: 10193489478457(each), 40193489478458(case), Lot Number: 21BBG092; 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

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-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-VC411Q-0730; Material REF: (1) N5391330, (2) N5391310, (3) N5777630; UDI-DI: (1) 04953170399329, (2) 04953170399329, (3) 04953170399329; 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) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005

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) DYNJ35363A, UDI-DI: 10884389516461(each), 40884389516462(case), Lot Number: 21BBP020; 2) SPTPCD10005, UDI-DI: 10080196228652(each), 40080196228653(case), Lot Number: 24JBB041
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

See complete list in RES, exceeds character limit. Medline Surgical Gowns

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) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525050165; 2) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525070175; 3) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525070223; 4) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525100047; 5) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525100144; 6) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525100377; 7) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525020078; 8) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525040212; 9) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525060247; 10) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525080205; 11) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525080306; 12) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525090277; 13) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30522040040; 14) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30524100129; 15) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30524100146; 16) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525010225; 17) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 72523120001; 18) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 72523120083; 19) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 72524010047; 20) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 72524010092; 21) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 72524120004; 22) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525050067; 23) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525050068; 24) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525070040; 25) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525070088; 26) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525070143; 27) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72525070001; 28) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525100019; 29) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525100119; 30) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525100124; 31) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525100187; 32) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72525100026; 33) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72525100098; 34) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525020140; 35) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72525020013; 36) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525040083; 37) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525060001; 38) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525060206; 39) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525060207; 40) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525080067; 41) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525080138; 42) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525080226; 43) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525090032; 44) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525090122; 45) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525090257; 46) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525110045; 47) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525110109; 48) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30519110009; 49) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30519110013; 50) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30519110023; 51) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520010003; 52) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520010007; 53) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520010008; 54) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520010012; 55) DYNJ… (truncated, 321973 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) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0800934D; 3) GENERAL ENDO PACK-LF, Model Number: DYNJ0842873J; 4) OR ANGIO PACK-LF, Model Number: DYNJ43415C; 5) ANGIO PACK II, Model Number: DYNJ44066A; 6) SOUTH CATH LAB PACK, Model Number: DYNJ61978A; 7) BIOPSY ANGIO TRAY ALEX, Model Number: DYNJ63542B; 8) SURGICAL TECH KIT, Model Number: DYNJ907452; 9) ANGIOGRAPHY PACK, Model Number: DYNJC2371G; 10) SPECTRUM HEALTH CATH PACK-LF, Model Number: PHS853965G

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) DYKE1743, UDI-DI: 10193489294606(each), 40193489294607(case), Lot Number: 23KBQ544; 2) DYKE1743, UDI-DI: 10193489294606(each), 40193489294607(case), Lot Number: 23JBO193; 3) DYNJ0800934D, UDI-DI: 10193489398885(each), 40193489398886(case), Lot Number: 21EBQ851; 4) DYNJ0800934D, UDI-DI: 10193489398885(each), 40193489398886(case), Lot Number: 21DBA951; 5) DYNJ0800934D, UDI-DI: 10193489398885(each), 40193489398886(case), Lot Number: 21BKA527; 6) DYNJ0800934D, UDI-DI: 10193489398885(each), 40193489398886(case), Lot Number: 21AKB217; 7) DYNJ0842873J, UDI-DI: 10193489448917(each), 40193489448918(case), Lot Number: 21ADA204; 8) DYNJ43415C, UDI-DI: 10193489901399(each), 40193489901390(case), Lot Number: 22EBI127; 9) DYNJ43415C, UDI-DI: 10193489901399(each), 40193489901390(case), Lot Number: 22EBF322; 10) DYNJ43415C, UDI-DI: 10193489901399(each), 40193489901390(case), Lot Number: 22CBF108; 11) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 22CLA012; 12) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 22BLA508; 13) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 21KLA332; 14) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 21HLA812; 15) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 21CLA325; 16) DYNJ61978A, UDI-DI: 10193489729306(each), 40193489729307(case), Lot Number: 20LDB953; 17) DYNJ63542B, UDI-DI: 10193489398632(each), 40193489398633(case), Lot Number: 23DBP359; 18) DYNJ907452, UDI-DI: 10193489422887(each), 40193489422888(case), Lot Number: 20LBW791; 19) DYNJC2371G, UDI-DI: 10889942494675(each), 40889942494676(case), Lot Number: 23BBT999; 20) PHS853965G, UDI-DI: 10193489249460(each), 40193489249461(case), Lot Number: 21ADA067
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

Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA; 2) ENDO KIT W/SYRINGE, Model Number:DYKE1743; 3) BGMC ANGIOGRAPHY PACK-LF, Model Number:DYNJ0800934D; 4) GENERAL ENDO PACK-LF, Model Number:DYNJ0842873J; 5) ANGIO PROCEDURE PACK, Model Number:DYNJ32328; 6) OR ANGIO PACK-LF, Model Number:DYNJ43415C; 7) ANGIO PACK II, Model Number:DYNJ44066A; 8) SOUTH CATH LAB PACK, Model Number:DYNJ61978A; 9) BIOPSY ANGIO TRAY ALEX, Model Number:DYNJ63542B; 10) SURGICAL TECH KIT, Model Number:DYNJ907452; 11) ANGIOGRAPHY PACK, Model Number:DYNJC2371G; 12) SPECTRUM HEALTH CATH PACK-LF, Model Number:PHS853965G

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) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 23ABN008; 2) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 23CBM469; 3) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 23EBH500; 4) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 23GBE369; 5) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 23IBE051; 6) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 23IBU695; 7) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 23KBD600; 8) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 23LBC152; 9) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 24ABR800; 10) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 24CBC183; 11) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 24DBS738; 12) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 24FBN230; 13) 00-401824AA, UDI-DI: 10193489455885(each), 40193489455886(case), Lot Number: 24HBB532; 14) DYKE1743, UDI-DI: 10193489294606(each), 40193489294607(case), Lot Number: 23JBO193; 15) DYKE1743, UDI-DI: 10193489294606(each), 40193489294607(case), Lot Number: 23KBQ544; 16) DYKE1743, UDI-DI: 10193489294606(each), 40193489294607(case), Lot Number: 23LBJ521; 17) DYNJ0800934D, UDI-DI: 10193489398885(each), 40193489398886(case), Lot Number: 21AKB217; 18) DYNJ0800934D, UDI-DI: 10193489398885(each), 40193489398886(case), Lot Number: 21BKA527; 19) DYNJ0800934D, UDI-DI: 10193489398885(each), 40193489398886(case), Lot Number: 21DBA951; 20) DYNJ0800934D, UDI-DI: 10193489398885(each), 40193489398886(case), Lot Number: 21EBQ851; 21) DYNJ0842873J, UDI-DI: 10193489448917(each), 40193489448918(case), Lot Number: 21ADA204; 22) DYNJ32328, UDI-DI: 10884389206669(each), 40884389206660(case), Lot Number: 24DBM071; 23) DYNJ43415C, UDI-DI: 10193489901399(each), 40193489901390(case), Lot Number: 23HBT948; 24) DYNJ43415C, UDI-DI: 10193489901399(each), 40193489901390(case), Lot Number: 22CBF108; 25) DYNJ43415C, UDI-DI: 10193489901399(each), 40193489901390(case), Lot Number: 22EBF322; 26) DYNJ43415C, UDI-DI: 10193489901399(each), 40193489901390(case), Lot Number: 22EBI127; 27) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 21CLA325; 28) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 21HLA812; 29) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 21KLA332; 30) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 22BLA508; 31) DYNJ44066A, UDI-DI: 10888277538023(each), 40888277538024(case), Lot Number: 22CLA012; 32) DYNJ61978A, UDI-DI: 10193489729306(each), 40193489729307(case), Lot Number: 20LDB953; 33) DYNJ63542B, UDI-DI: 10193489398632(each), 40193489398633(case), Lot Number: 23DBP359; 34) DYNJ907452, UDI-DI: 10193489422887(each), 40193489422888(case), Lot Number: 20LBW791; 35) DYNJC2371G, UDI-DI: 10889942494675(each), 40889942494676(case), Lot Number: 23BBT999; 36) PHS853965G, UDI-DI: 10193489249460(each), 40193489249461(case), Lot Number: 21ADA067
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 SURG ONC EXCISION BREAST, Model Number:DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number:DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number:DYNDH1143C; 4) BIOPSY SPECIALS PACK, Model Number:DYNDH1873; 5) BIOPSY SPECIALS PACK, Model Number:DYNDH1934; 6) BREAST BIOPSY PACK, Model Number:DYNJ17489I; 7) C T BIOPSY TRAY-LF, Model Number:DYNJ17558D; 8) RIGHT HEART BIOPSY TRAY, Model Number:DYNJ19063K; 9) VOR PACK-LF, Model Number:DYNJ48539; 10) VOR PACK-LF, Model Number:DYNJ48539A; 11) IR BIOPSY PACK, Model Number:DYNJ59897B; 12) BREAST PACK, Model Number:DYNJ82998; 13) LIVER BIOPSY KIT, Model Number:DYNJ910654

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) DYKMBNDL84A, UDI-DI: 10195327240486(each), 40195327240487(case), Lot Number: 22IBQ267; 2) DYKMBNDL84A, UDI-DI: 10195327240486(each), 40195327240487(case), Lot Number: 22IBU924; 3) DYKMBNDL84A, UDI-DI: 10195327240486(each), 40195327240487(case), Lot Number: 23ABK216; 4) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 22LBK913; 5) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 22LBM302; 6) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 23ABU170; 7) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 23CBC364; 8) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 23CBL439; 9) DYNDH1143C, UDI-DI: 10193489193336(each), 40193489193337(case), Lot Number: 22GBZ268; 10) DYNDH1873, UDI-DI: 10195327486464(each), 40195327486465(case), Lot Number: 23KBK476; 11) DYNDH1934, UDI-DI: 10195327519728(each), 40195327519729(case), Lot Number: 24FMF173; 12) DYNJ17489I, UDI-DI: 10195327224783(each), 40195327224784(case), Lot Number: 23CBL337; 13) DYNJ17558D, UDI-DI: 10195327504205(each), 40195327504206(case), Lot Number: 23JLB107; 14) DYNJ19063K, UDI-DI: 10888277828025(each), 40888277828026(case), Lot Number: 24DBL079; 15) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 20LME482; 16) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 20LMF497; 17) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 21JMC430; 18) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 22BMH767; 19) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 22EMD675; 20) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23AMC919; 21) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23DMD933; 22) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23GBI270; 23) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23HBR688; 24) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23KBD033; 25) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24ABL751; 26) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24DBK656; 27) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24EBQ366; 28) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24GBD309; 29) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 24IBT900; 30) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25EBA588; 31) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25HBK043; 32) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25IBA545; 33) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25JBA908; 34) DYNJ59897B, UDI-DI: 10195327043179(each), 40195327043170(case), Lot Number: 22LBH614; 35) DYNJ59897B, UDI-DI: 10195327043179(each), 40195327043170(case), Lot Number: 23EBQ760; 36) DYNJ59897B, UDI-DI: 10195327043179(each), 40195327043170(case), Lot Number: 23FBT785; 37) DYNJ59897B, UDI-DI: 10195327043179(each), 40195327043170(case), Lot Number: 23LBA546; 38) DYNJ82998, UDI-DI: 10195327222987(each), 40195327222988(case), Lot Number: 22JMG410; 39) DYNJ82998, UDI-DI: 10195327222987(each), 40195327222988(case), Lot Number: 22LMF004; 40) DYNJ910654, UDI-DI: 10198459055843(each), 40198459055844(case), Lot Number: 25CBM821; 41) DYNJ910654, UDI-DI: 10198459055843(each), 40198459055844(case), Lot Number: 25DBP029; 42) DYNJ910654, UDI-DI: 10198459055843(each), 40198459055844(case), Lot Number: 25EBU142; 43) DYNJ910654, UDI-DI: 10198459055843(each), 40198459055844(case), Lot Number: 25GBO011; 44) DYNJ910654, UDI-DI: 10198459055843(each), 40198459055844(case), Lot Number: 25HBG682
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) DENTAL PACK, Model Number: DYNDA3003

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) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24EMC989; 2) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24CMF059A; 3) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24CMF059; 4) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 24BBH600; 5) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23JBH393; 6) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23GBA134; 7) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23CBV199; 8) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23CBT510; 9) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23CBN951; 10) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23BBS986; 11) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 23ABA768; 12) DYNDA3003, UDI-DI: 10195327257484(each), 40195327257485(case), Lot Number: 22JBH446
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) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) L & D PACK-LF, Model Number: DYNJ0456816O; 6) L & D PACK-LF, Model Number: DYNJ0456816P; 7) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ04692S; 8) VAGINAL DELIVERY PACK, Model Number: DYNJ16621B; 9) VAGINAL DELIVERY PACK, Model Number: DYNJ16621C; 10) DELIVERY PACK-LF, Model Number: DYNJ20546F; 11) VAGINAL DELIVERY PK, Model Number: DYNJ20979I; 12) VAGINAL DELIVERY PK, Model Number: DYNJ20979J; 13) VAGINAL DELIVERY PACK, Model Number: DYNJ24108D; 14) OB PACK-LF, Model Number: DYNJ26121I; 15) OB DELIVERY PACK, Model Number: DYNJ31024J; 16) OB DELIVERY PACK-LF, Model Number: DYNJ32139C; 17) DB VAG HYSTERECTOMY-LF, Model Number: DYNJ33590F; 18) MAJOR VAGINAL PACK, Model Number: DYNJ35488F; 19) ENS. ACCOUCHEMENT VAGINAL-LF, Model Number: DYNJ37331C; 20) VAG DELIVERY PACK, Model Number: DYNJ38481G; 21) VAG DELIVERY PACK, Model Number: DYNJ38481I; 22) VAG DELIVERY PACK, Model Number: DYNJ38481K; 23) OB PACK 2, Model Number: DYNJ39000D; 24) GYNECOLOGY VAGINAL KIT, Model Number: DYNJ40203A; 25) LABOR DELIVERY POUCH SCREEN, Model Number: DYNJ40918A; 26) L & D PACK WITHOUT INSTRUMENTS, Model Number: DYNJ44720B; 27) VAGINAL DELIVERY PACK, Model Number: DYNJ51377G; 28) FH VAG DELIVERY PK-LF, Model Number: DYNJ51794B; 29) VAGINAL DELIVERY PACK, Model Number: DYNJ55363A; 30) VAGINAL DELIVERY PACK, Model Number: DYNJ55363B; 31) MINOR VAGINAL PACK, Model Number: DYNJ61269B; 32) OB VAG DELIVERY PACK, Model Number: DYNJ61574; 33) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ61650; 34) OB-VAG PACK 9128190, Model Number: DYNJ62341; 35) HP VAGINAL DELIVERY PACK-LF, Model Number: DYNJ62402A; 36) L & D PACK, Model Number: DYNJ63216A; 37) L&D PACK, Model Number: DYNJ63757A; 38) GYN PACK DYNJ55833A, Model Number: DYNJ65145; 39) MINOR VAG PACK, Model Number: DYNJ68663; 40) UTHET TYLER OB PACK, Model Number: DYNJ68673A; 41) GYN VAGINAL PACK, Model Number: DYNJ68681; 42) VAGINAL DELIVERY PACK, Model Number: DYNJ69544A; 43) VAGINAL PACK, Model Number: DYNJ69774A; 44) LABOR & DELIVERY PACK-LF, Model Number: DYNJ84393; 45) DELIVERY PACK, Model Number: DYNJ87469A; 46) VAGINAL DELIVERY, Model Number: DYNJ901387A; 47) FLOYD DELIVERY, Model Number: DYNJ906937D; 48) OB VAGINAL MEDSTAR PACK-LF, Model Number: DYNJT3445; 49) OB PACK, Model Number: DYNJT5186; 50) VAGINAL DELIVERY KIT, Model Number: MNS13550A; 51) VAGINAL DELIVERY TRAY, Model Number: MNS7460A; 52) LABOR AND DELIVERY KIT, Model Number: MNS8950A

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) DYKM2326, UDI-DI: 10198459565748(each), 40198459565749(case), Lot Number: 25KMF765; 2) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 24ABK386; 3) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23KBV905; 4) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23KBA329; 5) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23HBR548; 6) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23EBP170; 7) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23BBT994; 8) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22LBB693; 9) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22KBS631; 10) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22IBB499; 11) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21LBX453; 12) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21KBM483; 13) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21JBQ910; 14) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21IBO498; 15) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21IBE978; 16) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21GBN267; 17) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21FBP760; 18) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21EBE875; 19) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21DBA335; 20) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21ABT654; 21) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21ABI982; 22) DYKMBNDL31, UDI-DI: 10193489478716(each), 40193489478717(case), Lot Number: 21ABC201; 23) DYKMBNDL38, UDI-DI: 10193489477757(each), 40193489477758(case), Lot Number: 21ABM087; 24) DYNJ0456816O, UDI-DI: 10195327435219(each), 40195327435210(case), Lot Number: 23JME434; 25) DYNJ0456816O, UDI-DI: 10195327435219(each), 40195327435210(case), Lot Number: 23JMC541; 26) DYNJ0456816P, UDI-DI: 10195327570545(each), 40195327570546(case), Lot Number: 24HMK119; 27) DYNJ04692S, UDI-DI: 10193489338454(each), 40193489338455(case), Lot Number: 21ADB239; 28) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 25DMH878; 29) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 25CME932; 30) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 25AME014; 31) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24JMB353; 32) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24IMF157; 33) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24GMJ484; 34) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24FMF250; 35) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24DMI443; 36) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24CMB999; 37) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24BMA554; 38) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 23KMJ818; 39) DYNJ16621C, UDI-DI: 10198459421297(each), 40198459421298(case), Lot Number: 25GMD428; 40) DYNJ20546F, UDI-DI: 10193489346084(each), 40193489346085(case), Lot Number: 22IMG976; 41) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22FMB686; 42) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22EMF465; 43) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22DMB332; 44) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22CME094; 45) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22AMA608; 46) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21KMB071; 47) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21JMA483; 48) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21IMD851; 49) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21HMD738; 50) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21GMB531; 51) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21DMD921; 52) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21CME149; 53) DYNJ20979J, UDI-DI: 10195327191733(each), 40195327191734(case), Lot Number: 23AMJ134; 54) DYNJ20979J, UDI-DI: 10195327191733(each), 40195327191734(case), Lot Number: 22LMA315; 55) DYNJ20979J, UDI-DI: 10195327191733(each), 40195327191734(case), Lot Number: 22IMH408; 56) DYNJ20979J, UDI-DI: 10195327191… (truncated, 17242 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) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number:DYNJ905567A

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) DYNJ0185290G, UDI-DI: 10193489378054(each), 40193489378055(case), Lot Number: 22LBQ336; 2) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 21EBE777; 3) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 21GBE802; 4) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 21IBH675; 5) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 21KBA253; 6) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 21KBR457; 7) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 22CBY841; 8) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 22HBF686; 9) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 22HBM263; 10) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 22HBP453; 11) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 22LBC300; 12) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 22NBF780; 13) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 23CBQ546; 14) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 23EBH550; 15) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 23FBG152; 16) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 23FBL644; 17) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 23HBG596; 18) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 23KBI089; 19) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 24BBN429; 20) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 24GBT983; 21) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 24HBP446
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) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005

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) DYNJ35363A, UDI-DI: 10884389516461(each), 40884389516462(case), Lot Number: 21BBP020; 2) SPTPCD10005, UDI-DI: 10080196228652(each), 40080196228653(case), Lot Number: 24JBB041
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 #:
98642
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

Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A

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) DYNJ63118A, UDI-DI: 10195327644291(each), 40195327644292(case), Lot Number: 25ABV005
Recalling firm:
Medline Industries, LP
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.

ALL 50 STATES
▸Full report

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

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-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-VC431Q-0730; Material REF: (1) N5391610, (2) N5391630, (3) N5777930; UDI-DI: (1) 04953170466434, (2) 04953170466434, (3) 04953170466434; 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) 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) 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.

ALL 50 STATES
▸Full report

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) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) LVAD DRIVELINE TRAY, Model Number: DM1035A; 3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A

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) DM1035, UDI-DI: 10653160327752(each), 653160327755(case), Lot Number: 2020042290; 2) DM1035, UDI-DI: 10653160327752(each), 653160327755(case), Lot Number: 2020052290; 3) DM1035, UDI-DI: 10653160327752(each), 653160327755(case), Lot Number: 2020072290; 4) DM1035, UDI-DI: 10653160327752(each), 653160327755(case), Lot Number: 2020082690; 5) DM1035A, UDI-DI: 10653160345251(each), 653160345254(case), Lot Number: 2022030390; 6) DM1035A, UDI-DI: 10653160345251(each), 653160345254(case), Lot Number: 2022072590; 7) DM1035A, UDI-DI: 10653160345251(each), 653160345254(case), Lot Number: 2023062390; 8) DM1035A, UDI-DI: 10653160345251(each), 653160345254(case), Lot Number: 2023101290; 9) DM1035A, UDI-DI: 10653160345251(each), 653160345254(case), Lot Number: 2025031190; 10) DM1035A, UDI-DI: 10653160345251(each), 653160345254(case), Lot Number: 2025051290; 11) DT8670A, UDI-DI: 653160177473(each), 10653160177470(case), Lot Number: 2020051390
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) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) MINOR VAGINAL #76-RF, Model Number: DYNJ27434R; 6) VAG HYST PACK, Model Number: DYNJ31344J; 7) VAG HYST PACK, Model Number: DYNJ31344K; 8) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393L; 9) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393M; 10) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393N; 11) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393O; 12) LAVH PACK, Model Number: DYNJ36712F; 13) D&C MINOR LITHOTOMY PACK, Model Number: DYNJ45090I; 14) D C HYSTEROSCOPY PACK-LF, Model Number: DYNJ45801C; 15) VAG HYST PACK (VHGSG)642-LF, Model Number: DYNJ47694I; 16) HYSTEROSCOPY D AND C PACK, Model Number: DYNJ51741B; 17) LAVH - N #668629 -N, Model Number: DYNJ58121C; 18) PK, GYN-MINOR-LITHO, Model Number: DYNJ59037B; 19) HYSTEROSCOPY PACK, Model Number: DYNJ59444G; 20) D AND C PACK, Model Number: DYNJ61282B; 21) VAGINAL HYSTERECTOMY, Model Number: DYNJ67161; 22) PERI GYN, Model Number: DYNJ67708A; 23) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713B; 24) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713C; 25) ANORECTAL PACK, Model Number: DYNJ83560; 26) D&C CDS, Model Number: DYNJ902560I; 27) HYSTEROSCOPY, Model Number: DYNJ903327K; 28) ROBOTIC HYST, Model Number: DYNJ903798G; 29) TLH KIT, Model Number: DYNJ908149; 30) LAVH TOTE, Model Number: DYNJ908340; 31) LAVH TOTE, Model Number: DYNJ908340A; 32) LAVH TOTE, Model Number: DYNJ908340B; 33) LAVH TOTE, Model Number: DYNJ908340D; 34) BRECKENRIDGE LAVH, Model Number: DYNJ910537; 35) VAG HYST PACK, Model Number: DYNJT3348; 36) LAVH PART B, Model Number: DYNJV0312G

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) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 24CBQ563; 2) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 24ABO363; 3) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 23IBV204; 4) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 23HBY878; 5) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 23GBE705; 6) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23HBI773; 7) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23FBD256; 8) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23FBC116; 9) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23CBS135; 10) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23CBL440; 11) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 22KBH451; 12) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 22KBH032; 13) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 22KBH028; 14) DYNJ0373807J, UDI-DI: 10193489942996(each), 40193489942997(case), Lot Number: 22EBC904; 15) DYNJ0373807K, UDI-DI: 10195327225681(each), 40195327225682(case), Lot Number: 22JBO175; 16) DYNJ0373807K, UDI-DI: 10195327225681(each), 40195327225682(case), Lot Number: 22HBV873; 17) DYNJ27434R, UDI-DI: 10195327107727(each), 40195327107728(case), Lot Number: 23EBQ683; 18) DYNJ31344J, UDI-DI: 10193489496604(each), 40193489496605(case), Lot Number: 21LBL067; 19) DYNJ31344J, UDI-DI: 10193489496604(each), 40193489496605(case), Lot Number: 21CBJ513; 20) DYNJ31344J, UDI-DI: 10193489496604(each), 40193489496605(case), Lot Number: 21ABP592; 21) DYNJ31344K, UDI-DI: 10195327089283(each), 40195327089284(case), Lot Number: 23CMG183; 22) DYNJ31344K, UDI-DI: 10195327089283(each), 40195327089284(case), Lot Number: 22KMC218; 23) DYNJ31344K, UDI-DI: 10195327089283(each), 40195327089284(case), Lot Number: 22CBV220; 24) DYNJ33393L, UDI-DI: 10195327302139(each), 40195327302130(case), Lot Number: 23EMG111; 25) DYNJ33393L, UDI-DI: 10195327302139(each), 40195327302130(case), Lot Number: 23BMG588; 26) DYNJ33393L, UDI-DI: 10195327302139(each), 40195327302130(case), Lot Number: 22LME145; 27) DYNJ33393M, UDI-DI: 10195327567323(each), 40195327567324(case), Lot Number: 24AMC141; 28) DYNJ33393N, UDI-DI: 10195327616960(each), 40195327616961(case), Lot Number: 24LME743; 29) DYNJ33393N, UDI-DI: 10195327616960(each), 40195327616961(case), Lot Number: 24HMH344; 30) DYNJ33393O, UDI-DI: 10198459244537(each), 40198459244538(case), Lot Number: 25CMI389; 31) DYNJ36712F, UDI-DI: 10195327148027(each), 40195327148028(case), Lot Number: 22KBH638; 32) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23HBF942; 33) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23GBF010; 34) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23FBJ953; 35) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23DBD471; 36) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23BBC494; 37) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22GBK309; 38) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22EBK097; 39) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22BBZ962; 40) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22ABL203; 41) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 21LBI132; 42) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 25LBE575; 43) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 25DBK709; 44) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 25ABN265; 45) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 24JBI039; 46) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 24GBV369; 47) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 24FBC228; 48) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23JBH886; 49) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23IBV025; 50) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23HBR561; 51) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23FBO439; 52) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23EBL258; 53) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23DBQ854; 54) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 22HBB055; 55) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 22GBG579; 56) DYNJ45801C, UDI-DI: 10193489870381(each),… (truncated, 9479 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)