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Recalls affecting New Mexico

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

16,342 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

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

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

See RES for complete list. 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;

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) CDS940087AG, UDI-DI: 10193489847260(each), 40193489847261(case), Lot Number: 21EBC900; 2) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 21GBI183; 3) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 21IBJ260; 4) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 21JBF936; 5) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 21KBH163; 6) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22BBY060; 7) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22EBA274; 8) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22EBF695; 9) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22EBG548; 10) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22GBE442; 11) CDS980832Q, UDI-DI: 10193489788655(each), 40193489788656(case), Lot Number: 21BBL223; 12) CDS980832Q, UDI-DI: 10193489788655(each), 40193489788656(case), Lot Number: 21FBS254; 13) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21GBR895; 14) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21IBU197; 15) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21IBV695; 16) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21KBB625; 17) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21KBQ650; 18) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21LBO219; 19) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22GBK858; 20) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22GBK859; 21) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22GBL549; 22) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22GBM598; 23) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22HBS531; 24) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22JBH355; 25) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22OBI093; 26) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22OBK666; 27) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23BBJ844; 28) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23BBK758; 29) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23CBG614; 30) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23DBR887; 31) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23EBW653; 32) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23GBP400; 33) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23IBF278; 34) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23JBI054; 35) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21GBB808; 36) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21GBV804; 37) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21JBO077; 38) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21KBF393; 39) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21LBC616; 40) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21LBL968; 41) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 21LBW480; 42) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22DBN516; 43) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22FBD583; 44) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22GBS172; 45) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22GBS173; 46) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22IBE748; 47) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23ABG351; 48) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23ABH483; 49) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23BBP326; 50) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23CBT556; 51) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23EBK295; 52) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23HBB398; 53) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23HBV259; 54) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23IBA514; 55) CDS980865V, UDI-DI: 10193489304206(each), 40193489304207(case), Lot Number: 21ABX303; 56) CDS980865V, UDI-DI: 10193489304206(each), 401… (truncated, 335108 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 #:
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)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; 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-VC412Q-0215; Material REF: (1) N5391410, (2) N5391430, (3) N5777730; UDI-DI: (1) 04953170371158, (2) 04953170371158, (3) 04953170371158; 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) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437

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) DYNJ15668R, UDI-DI: 10195327108502(each), 40195327108503(case), Lot Number: 23HMB037; 2) DYNJ42829B, UDI-DI: 10193489880151(each), 40193489880152(case), Lot Number: 22IBI084; 3) DYNJT3437, UDI-DI: 10198459325076(each), 40198459325077(case), Lot Number: 25FBK633
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) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Model Number:CDS840015AQ; 3) OPEN HEART CDS, Model Number:CDS840023T; 4) OFF PUMP CABG CDS, Model Number:CDS840087AI; 5) OFF PUMP CABG CDS, Model Number:CDS840087AK; 6) OFF PUMP CABG CDS, Model Number:CDS840087AL; 7) OFF PUMP CABG CDS, Model Number:CDS840087AM; 8) OPEN HEART, Model Number:CDS840150S; 9) OPEN HEART, Model Number:CDS840150T;

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) CDS840015AQ, UDI-DI: 10195327210144(each), 40195327210145(case), Lot Number: 23FLA191; 2) CDS840015AQ, UDI-DI: 10195327210144(each), 40195327210145(case), Lot Number: 24ILB176; 3) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21CKA394; 4) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21EBN817; 5) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21GBH886; 6) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21IBG586; 7) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21KBW667; 8) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21LBV113; 9) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22CBC309; 10) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22EBK678; 11) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22GBQ917; 12) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22HBU935; 13) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22JBT770; 14) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22JBU353; 15) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22KBJ798; 16) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22KBL256; 17) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22KBW565; 18) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22OBM690; 19) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23ABE738; 20) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23ABM709; 21) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23CBO830; 22) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23GBA105; 23) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23IBJ571; 24) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23IBJ759; 25) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23JBU616; 26) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23KBM369; 27) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23LBM199; 28) CDS840087AI, UDI-DI: 10193489847413(each), 40193489847414(case), Lot Number: 21DLA296; 29) CDS840087AI, UDI-DI: 10193489847413(each), 40193489847414(case), Lot Number: 21ELA419; 30) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23BLA242; 31) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23BLA602; 32) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23CLB259; 33) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23ELA870; 34) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23FLA144; 35) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23GLA152; 36) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23GLB213; 37) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23HLB120; 38) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23ILA911; 39) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23LLA114; 40) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 24ALA030; 41) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24ALA755; 42) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24CLA098; 43) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24CLA726; 44) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24DLA309; 45) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24ELA365; 46) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24FLA779; 47) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24GLA640; 48) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24HLA954; 49) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24ILA464; 50) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24JLA176; 51) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24KLA701; 52) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24LLA151; 53) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 25CLA121; 54) CDS840087AM, UDI-DI: 10198459311611(each), 40198459311612(case), Lot Number: 25DLA768; 55) CDS840087AM, UDI-DI: 10198459311611(each), 40198459311612(case), Lot Number: 25ELA946; 56) CDS840087AM, UDI-DI: 1019… (truncated, 137795 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-V411M-3025 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-3025; Material REF: N1090210; UDI-DI: N/A; 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) BASIC NERVE BLOCK TRAY W/LINEN, Model Number: PAIN0150C

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) PAIN0150C, UDI-DI: 10193489819571(each), 21JBV886(case), Lot Number: 21JBV886
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) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number: CDSCCR611O; 4) C-SECTION, Model Number: CDSCCR611P; 5) LUD C-SECTION-LF, Model Number: DYNJ0101616I; 6) C-SECTION TRAY, Model Number: DYNJ15494G; 7) C-SECTION TRAY-LF, Model Number: DYNJ19529O; 8) C-SECTION TRAY-LF, Model Number: DYNJ19529P; 9) C-SECTION TRAY-LF, Model Number: DYNJ19529Q; 10) C-SECTION TRAY-LF, Model Number: DYNJ19529R; 11) C-SECTION TRAY-LF, Model Number: DYNJ19529S; 12) C-SECTION PACK-LF, Model Number: DYNJ21550Q; 13) C-SECTION PACK, Model Number: DYNJ23544F; 14) C-SECTION PACK, Model Number: DYNJ32632F; 15) C-SECTION PACK QVH-LF, Model Number: DYNJ35100I; 16) C-SECTION PACK, Model Number: DYNJ35902F; 17) C-SECTION PACK-LF, Model Number: DYNJ38801F; 18) SCRIPPS SW C-SECTION PACK-LF, Model Number: DYNJ40129C; 19) C-SECTION, Model Number: DYNJ41444F; 20) C-SECTION PACK, Model Number: DYNJ49224I; 21) C-SECTION PACK, Model Number: DYNJ49771A; 22) C-SECTION PACK, Model Number: DYNJ49771B; 23) C SECTION PACK-LF, Model Number: DYNJ52387I; 24) C-SECTION PACK, Model Number: DYNJ53528B; 25) C SECTION PACK-LF, Model Number: DYNJ55367A; 26) C-SECTION PACK, Model Number: DYNJ56523C; 27) C-SECTION PACK, Model Number: DYNJ59387L; 28) C-SECTION PACK, Model Number: DYNJ59387M; 29) C-SECTION PACK, Model Number: DYNJ59387N; 30) C-SECTION PACK, Model Number: DYNJ59387O; 31) C-SECTION PACK, Model Number: DYNJ59387P; 32) C-SECTION TRAY, Model Number: DYNJ62707B; 33) C-SECTION PACK, Model Number: DYNJ64549B; 34) C SECTION PACK, Model Number: DYNJ67347A; 35) C SECTION PACK, Model Number: DYNJ69778A; 36) B-C SECTION BAYSTATE, Model Number: DYNJ900602I; 37) B-C SECTION BAYSTATE, Model Number: DYNJ900602K; 38) PAD C-SECTION, Model Number: DYNJ902134C; 39) RICH C-SECTION, Model Number: DYNJ902182J; 40) C-SECTION, Model Number: DYNJ902938J; 41) C-SECTION PACK, Model Number: DYNJ904329D; 42) OB DELIVERY KIT, Model Number: DYNJ904453C; 43) C-SECTION, Model Number: DYNJ904697F; 44) C-SECTION, Model Number: DYNJ906255B; 45) KIT C SECTION, Model Number: DYNJ906966G; 46) C SECTION, Model Number: DYNJ907999A; 47) KIT C SECTION OR, Model Number: DYNJ908350C; 48) C-SECTION, Model Number: DYNJ909058; 49) C SECTION, Model Number: DYNJ909475A; 50) C-SECTION PACK, Model Number: DYNJ909507; 51) C-SECTION, Model Number: DYNJ910199; 52) C-SECTION, Model Number: DYNJ910199A; 53) C SECTION TRAY, Model Number: DYNJT3407; 54) C-SECTION BASIN PACK, Model Number: OBP211C; 55) TR-C SECTION PACK-LF, Model Number: PHS583549002B

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) CDS820080N, UDI-DI: 10195327278014(each), 40195327278015(case), Lot Number: 23IMB818; 2) CDS983523G, UDI-DI: 10195327283681(each), 40195327283682(case), Lot Number: 23IBS984; 3) CDSCCR611O, UDI-DI: 10193489367904(each), 40193489367905(case), Lot Number: 21CBN328; 4) CDSCCR611O, UDI-DI: 10193489367904(each), 40193489367905(case), Lot Number: 21LBC555; 5) CDSCCR611O, UDI-DI: 10193489367904(each), 40193489367905(case), Lot Number: 21WBA953; 6) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22BBH774; 7) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22BBT090; 8) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22EBA155; 9) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22FBU296; 10) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22FBU297; 11) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22FBU298; 12) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22IBG757; 13) DYNJ0101616I, UDI-DI: 10193489248814(each), 40193489248815(case), Lot Number: 21ADA105; 14) DYNJ15494G, UDI-DI: 10193489961195(each), 40193489961196(case), Lot Number: 22LBS122; 15) DYNJ19529O, UDI-DI: 10195327297206(each), 40195327297207(case), Lot Number: 23CMB465; 16) DYNJ19529O, UDI-DI: 10195327297206(each), 40195327297207(case), Lot Number: 23DMH505; 17) DYNJ19529O, UDI-DI: 10195327297206(each), 40195327297207(case), Lot Number: 23FMF781; 18) DYNJ19529O, UDI-DI: 10195327297206(each), 40195327297207(case), Lot Number: 23IMB944; 19) DYNJ19529O, UDI-DI: 10195327297206(each), 40195327297207(case), Lot Number: 23IME367; 20) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 23JMD920; 21) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 23JMI854; 22) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 23LME909; 23) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24AMD085; 24) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24AMI385; 25) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24BMG152; 26) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24CMJ610; 27) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24EMB123; 28) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24EMD740; 29) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24FMB372; 30) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24GMF054; 31) DYNJ19529Q, UDI-DI: 10198459109362(each), 40198459109363(case), Lot Number: 24KMD458; 32) DYNJ19529Q, UDI-DI: 10198459109362(each), 40198459109363(case), Lot Number: 24LMH886; 33) DYNJ19529Q, UDI-DI: 10198459109362(each), 40198459109363(case), Lot Number: 25BMB041; 34) DYNJ19529R, UDI-DI: 10198459311031(each), 40198459311032(case), Lot Number: 25DMA214; 35) DYNJ19529R, UDI-DI: 10198459311031(each), 40198459311032(case), Lot Number: 25EMH398; 36) DYNJ19529R, UDI-DI: 10198459311031(each), 40198459311032(case), Lot Number: 25FMI427; 37) DYNJ19529R, UDI-DI: 10198459311031(each), 40198459311032(case), Lot Number: 25GMH469; 38) DYNJ19529R, UDI-DI: 10198459311031(each), 40198459311032(case), Lot Number: 25IMA090; 39) DYNJ19529S, UDI-DI: 10198459566257(each), 40198459566258(case), Lot Number: 25KMA045; 40) DYNJ21550Q, UDI-DI: 10193489830910(each), 40193489830911(case), Lot Number: 21BBM422; 41) DYNJ21550Q, UDI-DI: 10193489830910(each), 40193489830911(case), Lot Number: 21DBJ153; 42) DYNJ21550Q, UDI-DI: 10193489830910(each), 40193489830911(case), Lot Number: 21DBL994; 43) DYNJ23544F, UDI-DI: 10889942533053(each), 40889942533054(case), Lot Number: 23IMA860; 44) DYNJ32632F, UDI-DI: 10193489888966(each), 40193489888967(case), Lot Number: 22HMC526; 45) DYNJ35100I, UDI-DI: 10195327097608(each), 40195327097609(case), Lot Number: 23IME105; 46) DYNJ35902F, UDI-DI: 10193489920109(each), 40193489920100(case), Lot Number: 23ABF399; 47) DYNJ38801F, UDI-DI: 10195327113117(each), 40195327113118(case), Lot Number: 23IBK585; 48) DYNJ40129C, UDI-DI: 10193489441772(each), 40193489441773(case), Lot Number: 23AMJ303; 49) DYNJ41444F, UDI-DI: 10193489740974(each), 40193489740975(case), Lot Number: 22JMB590; 50) DYNJ49224I, UDI-DI: 10193489371352(each), 40193489371353(case), Lot Number: 21DDA358; 51) DYNJ49771A, UDI-DI: 10198459015717(each), 40198459015718(case), Lot Number: 24GBN350; 52) DYNJ49771B, UDI-DI: 10198459087776(each), 40198459087777(case), Lot Number: 24IBI305; 53) DYNJ52387I, UDI-DI: 10193489248272(each), 40193489248273(case), Lot Number: 21ADA540; 54) DYNJ53528B, UDI-DI: 10195327077303(each), 40195327077304(case), Lot Number: 23GBT514; 55) DYNJ55367A, UDI-DI: 10889942858903(each), 40889942858904(case), Lot Number: 24CBS240; 56) DYNJ56523C, UDI-DI: 10193489430264(each), 40193489430… (truncated, 14338 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) 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; 10) NEW LONDON MINOR CDS, Model Number: CDS982518M; 11) NEW LONDON MINOR CDS, Model Number: CDS982518N; 12) NEW LONDON MINOR CDS, Model Number: CDS982518O; 13) NEW LONDON MINOR CDS, Model Number: CDS982518P; 14) GENERAL LAPAROSCOPY CDS, Model Number: CDS983311J; 15) LAVH CDS, Model Number: CDS983411G; 16) NHP ROBOTIC GENERAL CDS, Model Number: CDS984244J; 17) ROBOTIC-LF, Model Number: CDS984543C; 18) CYSTO CDS, Model Number: CDS984592G; 19) CYSTO CDS, Model Number: CDS984592I; 20) ROBOTIC, Model Number: CDS985270F; 21) GENERAL LAPAROSCOPY CDS, Model Number: CDS985422I; 22) ROBOTIC CDS, Model Number: CDS985429L; 23) LAP CHOLE CDS, Model Number: CDS985558N; 24) LAP CHOLE CDS, Model Number: CDS985558O; 25) ENDO KIT, Model Number: DYKE1580A; 26) KIT GEN SURG EXLAP, Model Number: DYKMBNDL105; 27) KIT GEN SURG EXLAP, Model Number: DYKMBNDL105A; 28) KIT GEN SURG EXLAP, Model Number: DYKMBNDL105B; 29) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116; 30) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116B; 31) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117A; 32) KIT SURG ONC DIAGNOSTIC LAPARO, Model Number: DYKMBNDL12; 33) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121; 34) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121A; 35) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121B; 36) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121C; 37) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121F; 38) KIT L&D CYSTO SETUP, Model Number: DYKMBNDL135A; 39) KIT THORACIC LAPAROSCOPIC HIAT, Model Number: DYKMBNDL136; 40) KIT THORACIC LAPAROSCOPIC HIAT, Model Number: DYKMBNDL136A; 41) KIT THORACIC STAGING LAPAROTOM, Model Number: DYKMBNDL15; 42) KIT SURG ONC LAP DIAG/CV CATH, Model Number: DYKMBNDL153A; 43) KIT SURG ONC LAP DIAG/PORT INS, Model Number: DYKMBNDL153B; 44) KIT LAP DONOR NEPHRECTOMY, Model Number: DYKMBNDL173; 45) KIT LAP DONOR NEPHRECTOMY, Model Number: DYKMBNDL173A; 46) KIT THORACIC HIATAL HERNIA TRA, Model Number: DYKMBNDL175; 47) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176; 48) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176A; 49) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176B; 50) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176C; 51) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184; 52) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184A; 53) KIT UROLOGY PENILE REPAIR, Model Number: DYKMBNDL188A; 54) KIT UROLOGY LAP SIDDIQUI, Model Number: DYKMBNDL193; 55) KIT UROLOGY LAP SIDDIQUI, Model Number: DYKMBNDL193A; 56) KIT UROLOGY BUCCAL GRAFT, Model Number: DYKMBNDL206; 57) KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54A; 58) KIT UROLOGY CYSTOSCOPY SUPPLEM, Model Number: DYKMBNDL60; 59) KIT UROLOGY CYSTOSCOPY SUPPLEM, Model Number: DYKMBNDL60A; 60) KIT UROLOGY MINOR, Model Number: DYKMBNDL61A; 61) KIT UROLOGY MINOR, Model Number: DYKMBNDL61B; 62) KIT GEN SURG LAP COLECTOMY, Model Number: DYKMBNDL73; 63) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73A; 64) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73B; 65) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73C; 66) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73D; 67) KIT GEN SURG LAP GASTRIC BYPAS, Model Number: DYKMBNDL74; 68) KIT GEN SURG LAP GASTRIC BYPAS, Model Number: DYKMBNDL74A; 69) KIT GEN SURG LAP GASTRIC BYPAS, Model Number: DYKMBNDL74B; 70) KIT GEN SURG LAP GASTRIC BYPAS,

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) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21LBT172; 2) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21LBD726; 3) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21KBB595; 4) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21IBL031; 5) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21GBS688; 6) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21FBR386; 7) CDS860015V, UDI-DI: 10195327209582(each), 40195327209583(case), Lot Number: 22HBF170; 8) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23LBQ388; 9) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23KBX194; 10) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23JBR469; 11) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23HBT489; 12) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23GBM065; 13) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23FBP597; 14) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 25EBQ940; 15) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 25DBF532; 16) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 24EBA340; 17) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 24DBP400; 18) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 24DBC504; 19) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 22FBQ637; 20) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 22FBH684; 21) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 22BBL530; 22) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 22ABD367; 23) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21KBI389; 24) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21GBV762; 25) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21GBV761; 26) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21FBC634; 27) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21EBD212; 28) CDS860016Q, UDI-DI: 10195327209599(each), 40195327209590(case), Lot Number: 23ABM653; 29) CDS860016Q, UDI-DI: 10195327209599(each), 40195327209590(case), Lot Number: 22KBA835; 30) CDS860016Q, UDI-DI: 10195327209599(each), 40195327209590(case), Lot Number: 22JBE511; 31) CDS860016R, UDI-DI: 10195327349479(each), 40195327349470(case), Lot Number: 24BBK121; 32) CDS860016R, UDI-DI: 10195327349479(each), 40195327349470(case), Lot Number: 23KBP519; 33) CDS860016R, UDI-DI: 10195327349479(each), 40195327349470(case), Lot Number: 23IBO655; 34) CDS860016R, UDI-DI: 10195327349479(each), 40195327349470(case), Lot Number: 23GBD634; 35) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 25LMH226; 36) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 25JBA926; 37) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 25FBG578; 38) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 25DBK311; 39) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24LBS320; 40) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24KBA566; 41) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24HBG876; 42) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24GBQ718; 43) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24DBJ711; 44) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24CBD741; 45) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 23ABM631; 46) CDS982518M, UDI-DI: 10193489401028(each), 40193489401029(case), Lot Number: 22EBC713; 47) CDS982518M, UDI-DI: 10193489401028(each), 40193489401029(case), Lot Number: 22BBZ407; 48) CDS982518M, UDI-DI: 10193489401028(each), 40193489401029(case), Lot Number: 21KBE056; 49) CDS982518M, UDI-DI: 10193489401028(each), 40193489401029(case), Lot Number: 21HBH225; 50) CDS982518M, UDI-DI: 10193489401028(each), 40193489401029(case), Lot Number: 21FBI691; 51) CDS982518N, UDI-DI: 10195327144166(each), 40195327144167(case), Lot Number: 22HBS430; 52) CDS982518N, UDI-DI: 10195327144166(each), 40195327144167(case), Lot Number: 22HBA456; 53) CDS982518O, UDI-DI: 10195327247386(each), 40195327247387(case), Lot Number: 23ABD137; 54) CDS982518O, UDI-DI: 10195327247386(each), 40195327247387(case), Lot Number: 22LBC678; 55) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 24BBO559; 56) CDS982518P, UDI-DI: 10195327318857(each), 4019532731885… (truncated, 138514 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) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T; 3) OFF PUMP CABG CDS, Model Number: CDS840087AI; 4) OFF PUMP CABG CDS, Model Number: CDS840087AK; 5) OFF PUMP CABG CDS, Model Number: CDS840087AL; 6) OPEN HEART, Model Number: CDS840150S; 7) OPEN HEART, Model Number: CDS840150T; 8) OPEN HEART, Model Number: CDS840150U; 9) OPEN HEART, Model Number: CDS840150V; 10) OPEN HEART, Model Number: CDS840150W; 11) UNIVERSAL HEART CDS, Model Number: CDS840246O; 12) GENERAL AAA #11-RF, Model Number: CDS840261AB; 13) OPEN HEART ADULT, Model Number: CDS840396AA; 14) OPEN HEART ADULT, Model Number: CDS840396AB; 15) OPEN HEART ADULT, Model Number: CDS840396X; 16) OPEN HEART ADULT, Model Number: CDS840396Y; 17) OPEN HEART CDS, Model Number: CDS840428K; 18) OPEN HEART CDS, Model Number: CDS840428L; 19) PACEMAKER CDS, Model Number: CDS980839C; 20) KIT, CVC ADD A PACK HUM-LF, Model Number: CDS982564C; 21) OPEN HEART ADULT HUM, Model Number: CDS982566K; 22) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575K; 23) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575M; 24) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575O; 25) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575P; 26) OPEN HEART, Model Number: CDS983348S; 27) HEART CABG CDS, Model Number: CDS983376Q; 28) HEART CABG CDS, Model Number: CDS983376T; 29) HEART CABG CDS, Model Number: CDS983376U; 30) HEART CABG CDS, Model Number: CDS983376V; 31) OPEN HEART CDS, Model Number: CDS983513F; 32) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786D; 33) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786F; 34) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786G; 35) PEDS CARDIAC CDS, Model Number: CDS984117F; 36) OPEN HEART CDS, Model Number: CDS984276P; 37) OPEN HEART ACCESSORY CDS, Model Number: CDS984289J; 38) OPEN HEART ACCESSORY CDS, Model Number: CDS984289K; 39) OPEN HEART ACCESSORY CDS, Model Number: CDS984289L; 40) OPEN HEART ACCESSORY CDS, Model Number: CDS984289M; 41) OPEN HEART ACCESSORY CDS, Model Number: CDS984289N; 42) OPEN HEART ACCESSORY CDS, Model Number: CDS984289O; 43) OPEN HEART CDS, Model Number: CDS984355F; 44) OPEN HEART CDS, Model Number: CDS984355G; 45) OPEN HEART CDS, Model Number: CDS984355I; 46) OPEN HEART CDS, Model Number: CDS984355J; 47) OPEN HEART A, Model Number: CDS985105M; 48) OPEN HEART A, Model Number: CDS985105N; 49) OPEN HEART A, Model Number: CDS985105O; 50) VASCULAR CDS, Model Number: CDS985215C; 51) BASE HEART PACK-LF, Model Number: CVT159AA; 52) ENDO KIT, Model Number: DYKE1580B; 53) KIT VASCULAR MINOR, Model Number: DYKMBNDL11; 54) KIT VASCULAR CAROTID, Model Number: DYKMBNDL118; 55) KIT VASCULAR CAROTID, Model Number: DYKMBNDL118A; 56) KIT VASCULAR BYPASS GRAFT GENE, Model Number: DYKMBNDL120; 57) KIT VASCULAR PERCUTANEOUS TEVA, Model Number: DYKMBNDL14; 58) KIT VASCULAR PERCUTANEOUS TEVA, Model Number: DYKMBNDL14A; 59) KIT VASCULAR VNS, Model Number: DYKMBNDL152; 60) KIT VASCULAR VNS, Model Number: DYKMBNDL152A; 61) KIT THORACIC SYMPHATECTOMY, Model Number: DYKMBNDL187; 62) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189B; 63) KIT VASCULAR ENDOVENOUS ABLATI, Model Number: DYKMBNDL191; 64) KIT VASCULAR ANGIOGRAM GENERIC, Model Number: DYKMBNDL192; 65) KIT VASCULAR ENDOVENOUS ABLATI, Model Number: DYKMBNDL203; 66) KIT VASCULAR MEDIAN ARCUATE, Model Number: DYKMBNDL209A; 67) KIT VASCULAR MEDIAN ARCUATE, Model Number: DYKMBNDL209B; 68) CARDIAC ADULT CABG, Model Number: DYKMBNDL20A; 69) CARDIAC ADULT CABG, Model Number: DYKMBNDL20B; 70) KIT CARDIAC CSICU ADULT ECMO, Model Number: DYKMBNDL21; 71) KIT VASCULAR AAA REPAIR, Model Number: DYKMBNDL23A; 72) KIT CARDIAC ANEURYSM, Model Number: DYKMBNDL27A; 73) KIT CARDIAC ANEURYSM, Model Number: DYKMBNDL27B; 74) KIT PEDS CARDIAC ADULT, Model Number: DYKMBNDL4

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) CDS840015AQ, UDI-DI: 10195327210144(each), 40195327210145(case), Lot Number: 23FLA191; 2) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23LBM199; 3) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23KBM369; 4) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23JBU616; 5) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23IBJ759; 6) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23IBJ571; 7) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23GBA105; 8) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23CBO830; 9) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23ABM709; 10) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 23ABE738; 11) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22OBM690; 12) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22KBW565; 13) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22KBL256; 14) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22KBJ798; 15) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22JBU353; 16) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22JBT770; 17) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22HBU935; 18) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22GBQ917; 19) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22EBK678; 20) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 22CBC309; 21) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21LBV113; 22) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21KBW667; 23) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21IBG586; 24) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21GBH886; 25) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21EBN817; 26) CDS840023T, UDI-DI: 10193489682069(each), 40193489682060(case), Lot Number: 21CKA394; 27) CDS840087AI, UDI-DI: 10193489847413(each), 40193489847414(case), Lot Number: 21ELA419; 28) CDS840087AI, UDI-DI: 10193489847413(each), 40193489847414(case), Lot Number: 21DLA296; 29) CDS840087AK, UDI-DI: 10195327212353(each), 40195327212354(case), Lot Number: 23ELA870; 30) CDS840087AL, UDI-DI: 10195327590406(each), 40195327590407(case), Lot Number: 24KLA701; 31) CDS840150S, UDI-DI: 10193489862409(each), 40193489862400(case), Lot Number: 21EBK732; 32) CDS840150S, UDI-DI: 10193489862409(each), 40193489862400(case), Lot Number: 21DBA306; 33) CDS840150T, UDI-DI: 10193489996197(each), 40193489996198(case), Lot Number: 21JBA896; 34) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22LBS336; 35) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22JBD465; 36) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22GBD762; 37) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22EBL398; 38) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22CBF996; 39) CDS840150U, UDI-DI: 10195327055318(each), 40195327055319(case), Lot Number: 22ABA269; 40) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 24ABJ652; 41) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23KBC879; 42) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23KBC675; 43) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23HBJ716; 44) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23EBB628; 45) CDS840150V, UDI-DI: 10195327298401(each), 40195327298402(case), Lot Number: 23DBN632; 46) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24FBP521; 47) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24FBP520; 48) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24EBK094; 49) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24DBB189; 50) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24CBQ331; 51) CDS840246O, UDI-DI: 10198459095955(each), 40198459095956(case), Lot Number: 25BLA225; 52) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 25EBF565; 53) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 25CBO300; 54) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 25ABU765; 55) CDS840261AB, UDI-DI: 10195327104535(each), 40195327104536(case), Lot Number: 25ABA041; 56) CDS840261AB, UDI-DI: 10195327104535(each), 401… (truncated, 108448 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-V411M-3030 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-3030; Material REF: (1) N5411830, (2) N1090310; UDI-DI: (1)04953170184154, (2)N/A; 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

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.

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-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

Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A

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) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25HBD027; 2) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25FBD161; 3) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25EBN454; 4) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25EBG142; 5) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25EBE995; 6) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25DBE771; 7) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25CBB549; 8) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25BBS071; 9) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 25BBB895; 10) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 24FBK537; 11) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 24CBK339; 12) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 24ABH890; 13) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 23KBA331; 14) DYKMBNDL200A, UDI-DI: 10195327240592(each), 40195327240593(case), Lot Number: 22KBD675
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-V411M-0330; 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-0330; Material REF: (1) N1089530, (2) N1089510, (3) N5411230; UDI-DI: (1) 04953170380563, (2) 04953170380563, (3) 04953170380563; 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) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number: CDSCCR611O; 4) C-SECTION, Model Number: CDSCCR611P; 5) LUD C-SECTION-LF, Model Number: DYNJ0101616I; 6) C-SECTION TRAY, Model Number: DYNJ15494G; 7) C-SECTION TRAY-LF, Model Number: DYNJ19529P; 8) C-SECTION TRAY-LF, Model Number: DYNJ19529Q; 9) C-SECTION TRAY-LF, Model Number: DYNJ19529R; 10) C-SECTION TRAY-LF, Model Number: DYNJ19529S; 11) C-SECTION PACK-LF, Model Number: DYNJ21550Q; 12) C-SECTION PACK, Model Number: DYNJ23544F; 13) C-SECTION PACK, Model Number: DYNJ32632F; 14) C-SECTION PACK QVH-LF, Model Number: DYNJ35100I; 15) C-SECTION PACK-LF, Model Number: DYNJ38801F; 16) SCRIPPS SW C-SECTION PACK-LF, Model Number: DYNJ40129C; 17) C-SECTION, Model Number: DYNJ41444F; 18) C-SECTION PACK, Model Number: DYNJ49224I; 19) C SECTION PACK-LF, Model Number: DYNJ52387I; 20) C-SECTION PACK, Model Number: DYNJ56523C; 21) C-SECTION PACK, Model Number: DYNJ59387L; 22) C-SECTION PACK, Model Number: DYNJ64549B; 23) C SECTION PACK, Model Number: DYNJ67347A; 24) C SECTION PACK, Model Number: DYNJ69778A; 25) B-C SECTION BAYSTATE, Model Number: DYNJ900602I; 26) B-C SECTION BAYSTATE, Model Number: DYNJ900602K; 27) PAD C-SECTION, Model Number: DYNJ902134C; 28) RICH C-SECTION, Model Number: DYNJ902182J; 29) C-SECTION PACK, Model Number: DYNJ904329D; 30) C-SECTION, Model Number: DYNJ904697F; 31) KIT C SECTION, Model Number: DYNJ906966G; 32) C SECTION, Model Number: DYNJ907999A; 33) C-SECTION, Model Number: DYNJ909058; 34) C-SECTION PACK, Model Number: DYNJ909507; 35) C SECTION TRAY, Model Number: DYNJT3407; 36) TR-C SECTION PACK-LF, Model Number: PHS583549002B

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) CDS820080N, UDI-DI: 10195327278014(each), 40195327278015(case), Lot Number: 23IMB818; 2) CDS983523G, UDI-DI: 10195327283681(each), 40195327283682(case), Lot Number: 23IBS984; 3) CDSCCR611O, UDI-DI: 10193489367904(each), 40193489367905(case), Lot Number: 21WBA953; 4) CDSCCR611O, UDI-DI: 10193489367904(each), 40193489367905(case), Lot Number: 21LBC555; 5) CDSCCR611O, UDI-DI: 10193489367904(each), 40193489367905(case), Lot Number: 21CBN328; 6) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22IBG757; 7) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22FBU298; 8) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22FBU297; 9) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22FBU296; 10) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22EBA155; 11) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22BBT090; 12) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22BBH774; 13) DYNJ0101616I, UDI-DI: 10193489248814(each), 40193489248815(case), Lot Number: 21ADA105; 14) DYNJ15494G, UDI-DI: 10193489961195(each), 40193489961196(case), Lot Number: 22LBS122; 15) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24GMF054; 16) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24FMB372; 17) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24EMB123; 18) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24AMD085; 19) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 23LME909; 20) DYNJ19529Q, UDI-DI: 10198459109362(each), 40198459109363(case), Lot Number: 25BMB041; 21) DYNJ19529Q, UDI-DI: 10198459109362(each), 40198459109363(case), Lot Number: 24LMH886; 22) DYNJ19529Q, UDI-DI: 10198459109362(each), 40198459109363(case), Lot Number: 24KMD458; 23) DYNJ19529R, UDI-DI: 10198459311031(each), 40198459311032(case), Lot Number: 25IMA090; 24) DYNJ19529R, UDI-DI: 10198459311031(each), 40198459311032(case), Lot Number: 25FMI427; 25) DYNJ19529S, UDI-DI: 10198459566257(each), 40198459566258(case), Lot Number: 25KMA045; 26) DYNJ21550Q, UDI-DI: 10193489830910(each), 40193489830911(case), Lot Number: 21DBL994; 27) DYNJ21550Q, UDI-DI: 10193489830910(each), 40193489830911(case), Lot Number: 21DBJ153; 28) DYNJ21550Q, UDI-DI: 10193489830910(each), 40193489830911(case), Lot Number: 21BBM422; 29) DYNJ23544F, UDI-DI: 10889942533053(each), 40889942533054(case), Lot Number: 23IMA860; 30) DYNJ32632F, UDI-DI: 10193489888966(each), 40193489888967(case), Lot Number: 22HMC526; 31) DYNJ35100I, UDI-DI: 10195327097608(each), 40195327097609(case), Lot Number: 23IME105; 32) DYNJ38801F, UDI-DI: 10195327113117(each), 40195327113118(case), Lot Number: 23IBK585; 33) DYNJ40129C, UDI-DI: 10193489441772(each), 40193489441773(case), Lot Number: 23AMJ303; 34) DYNJ41444F, UDI-DI: 10193489740974(each), 40193489740975(case), Lot Number: 22JMB590; 35) DYNJ49224I, UDI-DI: 10193489371352(each), 40193489371353(case), Lot Number: 21DDA358; 36) DYNJ52387I, UDI-DI: 10193489248272(each), 40193489248273(case), Lot Number: 21ADA540; 37) DYNJ56523C, UDI-DI: 10193489430264(each), 40193489430265(case), Lot Number: 21ABS513; 38) DYNJ59387L, UDI-DI: 10195327159856(each), 40195327159857(case), Lot Number: 23CBK420; 39) DYNJ64549B, UDI-DI: 10193489940725(each), 40193489940726(case), Lot Number: 23ABL355; 40) DYNJ67347A, UDI-DI: 10195327046156(each), 40195327046157(case), Lot Number: 22JMF954; 41) DYNJ69778A, UDI-DI: 10195327334420(each), 40195327334421(case), Lot Number: 23CBU899; 42) DYNJ900602I, UDI-DI: 10193489487121(each), 40193489487122(case), Lot Number: 20LDB302; 43) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 25JDA979; 44) DYNJ902134C, UDI-DI: 10193489452280(each), 40193489452281(case), Lot Number: 21DBP451; 45) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 23ABM580; 46) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22OBJ456; 47) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22JBO865; 48) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22IBI254; 49) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22HBF417; 50) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22GBH232; 51) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22EBG610; 52) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22DBN664; 53) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22ABY311; 54) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21JBX738; 55) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21JBJ172; 56) DYNJ902182J, UDI-DI: 10193489452914(eac… (truncated, 6773 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-V411M-1530 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-1530; Material REF: (1) N5411730, (2) N1090010; UDI-DI: (1)04953170380617, (2)N/A; 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 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

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; 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-0725; Material REF: (1) N1089710, (2) N5411430; UDI-DI: (1) 04953170380587, (2) 04953170380587; 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 Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-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.

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-0720; Material REF: (1) N5391530, (2) N5391510, (3) N5777830; UDI-DI: (1) 04953170466427, (2) 04953170466427, (3) 04953170466427; 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: 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.

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-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 (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

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 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-401Q-0730; Material REF: 5857030; UDI-DI: 04953170041709; 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

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 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-1520; Material REF: (1) N5411630, (2) N1089910; UDI-DI: (1)04953170380600, (2) N/A; 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 (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)