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Recalls affecting Kentucky

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

16,680 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.

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

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

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

Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950

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) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 24DBT832; 2) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 24CBH626; 3) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 23LBR075; 4) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 23FBF248; 5) DYNJ83950, UDI-DI: 10195327318925(each), 40195327318926(case), Lot Number: 23CBG610
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: DM1035A; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 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.

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

Recall #:
98329
Lot/product code:
1) DM1035A, UDI-DI: 10653160345251(each), 00653160345254(case), Lot Number: 2025051290; 2) DM1035A, UDI-DI: 10653160345251(each), 00653160345254(case), Lot Number: 2025031190; 3) DM1035A, UDI-DI: 10653160345251(each), 00653160345254(case), Lot Number: 2023062390; 4) DM1035A, UDI-DI: 10653160345251(each), 00653160345254(case), Lot Number: 2023101290; 5) DM1035A, UDI-DI: 10653160345251(each), 00653160345254(case), Lot Number: 2022030390; 6) DM1035A, UDI-DI: 10653160345251(each), 00653160345254(case), Lot Number: 2022072590; 7) DM1035, UDI-DI: 10653160327752(each), 00653160327755(case), Lot Number: 2020042290; 8) DM1035, UDI-DI: 10653160327752(each), 00653160327755(case), Lot Number: 2020052290; 9) DM1035, UDI-DI: 10653160327752(each), 00653160327755(case), Lot Number: 2020072290; 10) DM1035, UDI-DI: 10653160327752(each), 00653160327755(case), Lot Number: 2020082690; 11) DT8670A, UDI-DI: 00653160177473(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) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4; 4) NICU LINE CHANGE TRAY, Model Number: LC295; 5) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977C; 6) PICC CATHETER INSERTION TRAY, Model Number: CVI4300

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

Recall #:
98329
Lot/product code:
1) DYKMBNDL130, UDI-DI: 10193489479027(each), 40193489479028(case), Lot Number: 21BBB580; 2) DYKMBNDL130, UDI-DI: 10193489479027(each), 40193489479028(case), Lot Number: 21ABJ543; 3) DYKMBNDL130, UDI-DI: 10193489479027(each), 40193489479028(case), Lot Number: 21ABC197; 4) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22GLB021; 5) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22GLA694; 6) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22FLA745; 7) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22ELA008; 8) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22DLA407; 9) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22CLA448; 10) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22BLA721; 11) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22ALA593; 12) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21JLA910; 13) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21ILA163; 14) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21HLA740; 15) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21GLA677; 16) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21FLA214; 17) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21ELA080; 18) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21DLA326; 19) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21CLA621; 20) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21CLA391Z; 21) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21CLA391; 22) DYKMBNDL4, UDI-DI: 10193489477627(each), 40193489477628(case), Lot Number: 21DLA343; 23) DYKMBNDL4, UDI-DI: 10193489477627(each), 40193489477628(case), Lot Number: 21ALA631; 24) DYKMBNDL4, UDI-DI: 10193489477627(each), 40193489477628(case), Lot Number: 21ALA056; 25) LC295, UDI-DI: 10653160322702(each), 00653160322705(case), Lot Number: 2025110490; 26) DYKM1977C, UDI-DI: 10653160381105(each), 00653160381108(case), Lot Number: 2024110190; 27) CVI4300, UDI-DI: 10653160294313(each), 00653160294316(case), Lot Number: 2020120950
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) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2) TOTE SEN OSC HAND REPAIR, Model Number: DYKM1776; 3) TOTE MOMENI SB CAPSULOTOMY REC, Model Number: DYKM1765A; 4) TOTE YAO OSC HAND REPAIR, Model Number: DYKM1796A; 5) TOTE SB NGUYEN CAPSULOTOMY, Model Number: DYKM1756A; 6) TOTE FOX OSC HAND REPAIR, Model Number: DYKM1783A; 7) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 8) TOTE SB NGUYEN LIPOSUCTION, Model Number: DYKM1927A; 9) TOTE YAO OSC WRIST ARTHROSCOPY, Model Number: DYKM1807; 10) TOTE CURTIN OSC HAND REPAIR, Model Number: DYKM1781A; 11) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977B; 12) TOTE CHANGE OSC HAND REPAIR, Model Number: DYKM1751A; 13) TOTE CARROLL BLOCK BLOOD PATCH, Model Number: DYKM1864; 14) TOTE SB STONE JWIRE LUMPECTOMY/SEN NODE, Model Number: DYKM1925; 15) TOTE SAFRAN OSC HIP ARTHRSCPY, Model Number: DYKM1767B; 16) CVC PACK, Model Number: CVI4500A

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) DYKM1801B, UDI-DI: 10653160360421(each), 00653160360424(case), Lot Number: 2024100790; 2) DYKM1776, UDI-DI: 10888277733794(each), 20888277733791(case), Lot Number: 2025013190; 3) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2024071790; 4) DYKM1796A, UDI-DI: 10653160354888(each), 00653160354881(case), Lot Number: 2024072390; 5) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2024080190; 6) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2024101490; 7) DYKM1796A, UDI-DI: 10653160354888(each), 00653160354881(case), Lot Number: 2025010890; 8) DYKM1783A, UDI-DI: 10193489111330(each), 20193489111337(case), Lot Number: 2025011090; 9) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2025012890; 10) DYKM1796A, UDI-DI: 10653160354888(each), 00653160354881(case), Lot Number: 2025020690; 11) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2024012590; 12) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2024030690; 13) DYKM1796A, UDI-DI: 10653160354888(each), 00653160354881(case), Lot Number: 2024041790; 14) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2024052290; 15) DYKM1783A, UDI-DI: 10193489111330(each), 20193489111337(case), Lot Number: 2024053190; 16) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2024060590; 17) DYKM1796A, UDI-DI: 10653160354888(each), 00653160354881(case), Lot Number: 2024061890; 18) DYKM1783A, UDI-DI: 10193489111330(each), 20193489111337(case), Lot Number: 2024062890; 19) DYKM1807, UDI-DI: 10193489191219(each), 20193489191216(case), Lot Number: 2024071990; 20) DYKM1781A, UDI-DI: 10653160352730(each), 00653160352733(case), Lot Number: 2024092390; 21) DYKM1796A, UDI-DI: 10653160354888(each), 00653160354881(case), Lot Number: 2024093090; 22) DYKM1977B, UDI-DI: 10653160360797(each), 00653160360790(case), Lot Number: 2024091290; 23) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2024012490; 24) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2024022190; 25) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023120590; 26) DYKM1751A, UDI-DI: 10193489111002(each), 20193489111009(case), Lot Number: 2023121190; 27) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2023121490; 28) DYKM1776, UDI-DI: 10888277733794(each), 20888277733791(case), Lot Number: 2024031590; 29) DYKM1864, UDI-DI: 10193489191257(each), 20193489191254(case), Lot Number: 2024010880; 30) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023070590; 31) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2023071290; 32) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023111590; 33) DYKM1977B, UDI-DI: 10653160360797(each), 00653160360790(case), Lot Number: 2023120890; 34) DYKM1801B, UDI-DI: 10653160360421(each), 00653160360424(case), Lot Number: 2024011790; 35) DYKM1801B, UDI-DI: 10653160360421(each), 00653160360424(case), Lot Number: 2024062890; 36) DYKM1925, UDI-DI: 10193489190311(each), 20193489190318(case), Lot Number: 2024040180; 37) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2023072590; 38) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2023080190; 39) DYKM1927A, UDI-DI: 10193489199901(each), 20193489199908(case), Lot Number: 2023081490; 40) DYKM1767B, UDI-DI: 10193489112368(each), 20193489112365(case), Lot Number: 2023102790; 41) DYKM1864, UDI-DI: 10193489191257(each), 20193489191254(case), Lot Number: 2023101680; 42) DYKM1977B, UDI-DI: 10653160360797(each), 00653160360790(case), Lot Number: 2023063090; 43) DYKM1925, UDI-DI: 10193489190311(each), 20193489190318(case), Lot Number: 2023112780; 44) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2023050490; 45) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023060290; 46) DYKM1807, UDI-DI: 10193489191219(each), 20193489191216(case), Lot Number: 2024032990; 47) CVI4500A, UDI-DI: 10653160327646(each), 00653160327649(case), Lot Number: 2020121550
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 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.

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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

Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A;

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) DYNJ83185, UDI-DI: 10195327247058(each), 40195327247059(case), Lot Number: 23FDC392; 2) DYNJ83185, UDI-DI: 10195327247058(each), 40195327247059(case), Lot Number: 23CDB552; 3) DYNJ83185, UDI-DI: 10195327247058(each), 40195327247059(case), Lot Number: 23CDA474; 4) DYNJ83185, UDI-DI: 10195327247058(each), 40195327247059(case), Lot Number: 22LDA486; 5) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24KDB955; 6) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24IDB525; 7) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24GDB922; 8) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24FDB302; 9) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24EDB468; 10) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24DDB769; 11) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24CDB829; 12) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24CDB327; 13) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 24CDA984; 14) DYNJ83185A, UDI-DI: 10195327468606(each), 40195327468607(case), Lot Number: 23HDB637
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

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

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

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

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

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

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

ALL 50 STATES
▸Full report

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

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

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.

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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-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

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) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCHOSCOPY SETUP KIT, Model Number: DYKE1955; 6) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156; 7) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156A; 8) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156B; 9) KIT ENT LARYNGECTOMY, Model Number: DYKMBNDL174; 10) KIT ENT LARYNGECTOMY, Model Number: DYKMBNDL174A; 11) KIT ENT LARYNGECTOMY, Model Number: DYKMBNDL174B; 12) KIT PEDS HEAD AND NECK, Model Number: DYKMBNDL196; 13) KIT OMF LEFORTE, Model Number: DYKMBNDL1A; 14) KIT OMF LEFORTE, Model Number: DYKMBNDL1B; 15) KIT OMF LEFORTE, Model Number: DYKMBNDL1C; 16) KIT ENT ENDOSINUS GENERIC, Model Number: DYKMBNDL32; 17) KIT ENT ENDOSINUS GENERIC, Model Number: DYKMBNDL32A; 18) KIT ENT ENDOSINUS GENERIC, Model Number: DYKMBNDL32B; 19) KIT GEN SURG THYROIDECTOMY, Model Number: DYKMBNDL66A; 20) KIT GEN SURG THYROIDECTOMY, Model Number: DYKMBNDL66B; 21) KIT GEN SURG EXCISION THYROID, Model Number: DYKMBNDL88A; 22) KIT GEN SURG EXCISION THYROID, Model Number: DYKMBNDL88B; 23) KIT GEN SURG EXCISION THYROID, Model Number: DYKMBNDL88C; 24) KIT GEN SURG LAP VENTRA, Model Number: DYKMBNDL96C; 25) MINOR ENT PACK, Model Number: DYNJ01831I; 26) ENT BASIC PACK-LF, Model Number: DYNJ0387711F; 27) D AND C PACK-LF, Model Number: DYNJ0855090P; 28) CSS SINUS PACK, Model Number: DYNJ17005I; 29) CSS HEAD & NECK PACK, Model Number: DYNJ26780I; 30) NASALPLASTY #61-RF, Model Number: DYNJ27320V; 31) MASTOID PACK-WINTER PARK-LF, Model Number: DYNJ32060C; 32) T&A PACK, Model Number: DYNJ32809I; 33) HEAD AND NECK PACK, Model Number: DYNJ41169; 34) SIMPLE NECK DISSECTION, Model Number: DYNJ47481C; 35) ENT PACK, Model Number: DYNJ47882F; 36) ENT PACK, Model Number: DYNJ48401C; 37) ENT PACK, Model Number: DYNJ51934A; 38) PK,ORTHO-EXTREMITY-LOSROBLES, Model Number: DYNJ52916A; 39) HEAD & NECK PACK, Model Number: DYNJ54964A; 40) HEAD & NECK PACK, Model Number: DYNJ54964B; 41) ENT - MINOR ENT PACK-LF, Model Number: DYNJ56840B; 42) GLENNON HEAD AND NECK PACK-LF, Model Number: DYNJ57200C; 43) ENT PACK, Model Number: DYNJ57688F; 44) RF T AND A PACK, Model Number: DYNJ61393A; 45) T & A PACK, Model Number: DYNJ61935D; 46) ENT PACK, Model Number: DYNJ62093B; 47) ENT PACK, Model Number: DYNJ64024B; 48) OSCLJ HEAD AND NECK PACK, Model Number: DYNJ66509A; 49) HEAD AND NECK PACK, Model Number: DYNJ67208; 50) HEAD & NECK PACK, Model Number: DYNJ67328B; 51) PEDS HEAD AND NECK PACK, Model Number: DYNJ69746B; 52) NASAL PACK, Model Number: DYNJ81280A; 53) ENT-PLASTICS PACK, Model Number: DYNJ84258A; 54) ENT-PLASTICS PACK, Model Number: DYNJ84258B; 55) HEAD & NECK PACK, Model Number: DYNJ85078A; 56) ENT PACK, Model Number: DYNJ86194A; 57) EENT PACK, Model Number: DYNJ86235; 58) ENT PACK, Model Number: DYNJ87378; 59) ENT PACK, Model Number: DYNJ87378A; 60) ENT PACK, Model Number: DYNJ87378D; 61) ENT SPLIT PACK, Model Number: DYNJ87451; 62) ENT SINUS PACK, Model Number: DYNJ88498; 63) NASAL, Model Number: DYNJ902993F; 64) ENDO SINUS-MIDTOWN, Model Number: DYNJ905866; 65) T A, Model Number: DYNJ906292B; 66) THYROID, Model Number: DYNJ906841A; 67) THYROID - SMH AMB, Model Number: DYNJ907739B; 68) ENT, Model Number: DYNJ911623; 69) HEAD AND NECK PACK, Model Number: DYNJT5739; 70) RO MEDIASTINAL PACK-LF, Model Number: PHS393087007C

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) CDS983069G, UDI-DI: 10193489923926(each), 40193489923927(case), Lot Number: 21IBD399; 2) CDS983069G, UDI-DI: 10193489923926(each), 40193489923927(case), Lot Number: 21HBO921; 3) CDS983069I, UDI-DI: 10195327071868(each), 40195327071869(case), Lot Number: 22JBW315; 4) CDS983069I, UDI-DI: 10195327071868(each), 40195327071869(case), Lot Number: 22GBE731; 5) CDS983069I, UDI-DI: 10195327071868(each), 40195327071869(case), Lot Number: 22FBX804; 6) CDS983782C, UDI-DI: 10193489592047(each), 40193489592048(case), Lot Number: 21DKA756; 7) DYKE1456D, UDI-DI: 10195327639938(each), 40195327639939(case), Lot Number: 24CBK289; 8) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 25HLA345; 9) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 25FLA904; 10) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 25DLB145; 11) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 25CLB002; 12) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 24DLA606; 13) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 24ALA266; 14) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21FBS478; 15) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21FBO537; 16) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21DBJ855; 17) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21CBD340; 18) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21BBG062; 19) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21ABK323; 20) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22GBH498; 21) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22FBT038; 22) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22EBS812; 23) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22DBL428; 24) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22CBX230; 25) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22BBA231; 26) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22ABG015; 27) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21JBB014; 28) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21JBA009; 29) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21IBP624; 30) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21HBF494; 31) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21GBE737; 32) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25GBX739; 33) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25EBH975; 34) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25DBQ008; 35) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25BBM402; 36) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25ABK769; 37) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24KBJ157; 38) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24HBU706; 39) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24GBR935; 40) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24GBD477; 41) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24EBF125; 42) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24DBV609; 43) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24ABL113; 44) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23JBT911; 45) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23JBQ487; 46) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23HBV381; 47) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23HBT877; 48) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23FBG212; 49) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23EBS366; 50) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23DBM060; 51) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23ABQ109; 52) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 22KBH786; 53) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 22IBU647; 54) DYKMBNDL174, UDI-DI: 10193489478334(each), 40193489478335(case), Lot Number: 21FBQ554; 55) DYKMBNDL174, UDI-DI: 10193489478334(each), 40193489478335(case), Lot Number: 21BBP8… (truncated, 23354 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) 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) 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.

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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

Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55A; 3) TRACH TOTE, Model Number: DYNJ85691

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) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21FBA766; 2) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21DBB713; 3) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21CBH955; 4) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21ABX057; 5) DYKMBNDL55, UDI-DI: 10193489478839(each), 40193489478830(case), Lot Number: 21ABK325; 6) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 23CBN841; 7) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22LBK911; 8) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22KBH787; 9) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22HBQ099; 10) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22FBX191; 11) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22FBF305; 12) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22DBR042; 13) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22DBM224; 14) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22BBM867; 15) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22BBL555; 16) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22ABM691; 17) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 22ABD970; 18) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21WBA902; 19) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21JBJ227; 20) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21IBU128; 21) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21GBR277; 22) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21GBR275; 23) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21FBS122; 24) DYKMBNDL55A, UDI-DI: 10193489897890(each), 40193489897891(case), Lot Number: 21FBE305; 25) DYNJ85691, UDI-DI: 10195327534141(each), 40195327534142(case), Lot Number: 24ABR853
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) PPE KIT, Model Number: DYK1011945P

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

ALL 50 STATES
▸Full report

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

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

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

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

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

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

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.

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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) WMC I D PACK-LF, Model Number: DYNJ50806L

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

ALL 50 STATES
▸Full report

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

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

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-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
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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-0730; Material REF: (1) N1089810, (2) N5411530; UDI-DI: (1) 04953170380594, (2) 04953170380594; All Lots with a valid expiration date
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

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

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

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

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

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.

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-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) 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) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38B; 6) L & D PACK-LF, Model Number: DYNJ0456816O; 7) L & D PACK-LF, Model Number: DYNJ0456816P; 8) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ04692S; 9) VAGINAL DELIVERY PACK, Model Number: DYNJ16621B; 10) VAGINAL DELIVERY PACK, Model Number: DYNJ16621C; 11) DELIVERY PACK-LF, Model Number: DYNJ20546F; 12) VAGINAL DELIVERY PK, Model Number: DYNJ20979I; 13) VAGINAL DELIVERY PK, Model Number: DYNJ20979J; 14) VAGINAL DELIVERY PACK, Model Number: DYNJ24108D; 15) OB PACK-LF, Model Number: DYNJ26121I; 16) OB DELIVERY PACK, Model Number: DYNJ31024J; 17) OB DELIVERY PACK-LF, Model Number: DYNJ32139C; 18) DB VAG HYSTERECTOMY-LF, Model Number: DYNJ33590F; 19) MAJOR VAGINAL PACK, Model Number: DYNJ35488F; 20) ENS. ACCOUCHEMENT VAGINAL-LF, Model Number: DYNJ37331C; 21) VAG DELIVERY PACK, Model Number: DYNJ38481G; 22) VAG DELIVERY PACK, Model Number: DYNJ38481I; 23) VAG DELIVERY PACK, Model Number: DYNJ38481K; 24) OB PACK 2, Model Number: DYNJ39000D; 25) GYNECOLOGY VAGINAL KIT, Model Number: DYNJ40203A; 26) LABOR DELIVERY POUCH SCREEN, Model Number: DYNJ40918A; 27) L & D PACK WITHOUT INSTRUMENTS, Model Number: DYNJ44720B; 28) VAGINAL DELIVERY PACK, Model Number: DYNJ51377G; 29) FH VAG DELIVERY PK-LF, Model Number: DYNJ51794B; 30) VAGINAL DELIVERY PACK, Model Number: DYNJ55363A; 31) VAGINAL DELIVERY PACK, Model Number: DYNJ55363B; 32) DELIVERY PACK, Model Number: DYNJ55373A; 33) VAGINAL DELIVERY PACK, Model Number: DYNJ59403F; 34) MINOR VAGINAL PACK, Model Number: DYNJ61269B; 35) OB VAG DELIVERY PACK, Model Number: DYNJ61574; 36) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ61650; 37) OB-VAG PACK 9128190, Model Number: DYNJ62341; 38) HP VAGINAL DELIVERY PACK-LF, Model Number: DYNJ62402A; 39) LABOR AND DELIVERY TRAY, Model Number: DYNJ62722B; 40) L & D PACK, Model Number: DYNJ63216A; 41) L&D PACK, Model Number: DYNJ63757A; 42) GYN PACK DYNJ55833A, Model Number: DYNJ65145; 43) MINOR VAG PACK, Model Number: DYNJ68663; 44) UTHET TYLER OB PACK, Model Number: DYNJ68673A; 45) GYN VAGINAL PACK, Model Number: DYNJ68681; 46) VAGINAL DELIVERY PACK, Model Number: DYNJ69544A; 47) VAGINAL PACK, Model Number: DYNJ69774A; 48) LABOR & DELIVERY PACK-LF, Model Number: DYNJ84393; 49) DELIVERY PACK, Model Number: DYNJ87469A; 50) DELIVERY B, Model Number: DYNJ900351T; 51) VAGINAL DELIVERY, Model Number: DYNJ901387A; 52) FLOYD DELIVERY, Model Number: DYNJ906937D; 53) OB VAGINAL MEDSTAR PACK-LF, Model Number: DYNJT3445; 54) OB PACK, Model Number: DYNJT5186; 55) VAGINAL DELIVERY KIT, Model Number: MNS13550A; 56) VAGINAL DELIVERY TRAY, Model Number: MNS7460A; 57) 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 #:
98642
Lot/product code:
1) DYKM2326, UDI-DI: 10198459565748(each), 40198459565749(case), Lot Number: 25KMF765; 2) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21ABI982; 3) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21ABT654; 4) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21DBA335; 5) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21EBE875; 6) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21FBP760; 7) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21GBN267; 8) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21IBE978; 9) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21IBO498; 10) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21JBQ910; 11) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21KBM483; 12) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21LBX453; 13) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22IBB499; 14) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22KBS631; 15) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22LBB693; 16) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23BBT994; 17) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23EBP170; 18) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23HBR548; 19) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23KBA329; 20) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23KBV905; 21) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 24ABK386; 22) DYKMBNDL31, UDI-DI: 10193489478716(each), 40193489478717(case), Lot Number: 21ABC201; 23) DYKMBNDL31, UDI-DI: 10193489478716(each), 40193489478717(case), Lot Number: 23JLA066; 24) DYKMBNDL31, UDI-DI: 10193489478716(each), 40193489478717(case), Lot Number: 23JLA538; 25) DYKMBNDL38, UDI-DI: 10193489477757(each), 40193489477758(case), Lot Number: 21ABM087; 26) DYKMBNDL38, UDI-DI: 10193489477757(each), 40193489477758(case), Lot Number: 23IBT256; 27) DYKMBNDL38, UDI-DI: 10193489477757(each), 40193489477758(case), Lot Number: 23JBB705; 28) DYKMBNDL38B, UDI-DI: 10195327660017(each), 40195327660018(case), Lot Number: 24IBK537; 29) DYKMBNDL38B, UDI-DI: 10195327660017(each), 40195327660018(case), Lot Number: 24IBM370; 30) DYKMBNDL38B, UDI-DI: 10195327660017(each), 40195327660018(case), Lot Number: 24IBW265; 31) DYKMBNDL38B, UDI-DI: 10195327660017(each), 40195327660018(case), Lot Number: 24JBK520; 32) DYNJ0456816O, UDI-DI: 10195327435219(each), 40195327435210(case), Lot Number: 23JMC541; 33) DYNJ0456816O, UDI-DI: 10195327435219(each), 40195327435210(case), Lot Number: 23JME434; 34) DYNJ0456816P, UDI-DI: 10195327570545(each), 40195327570546(case), Lot Number: 24HMK119; 35) DYNJ04692S, UDI-DI: 10193489338454(each), 40193489338455(case), Lot Number: 21ADB239; 36) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 23KMJ818; 37) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24BMA554; 38) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24CMB999; 39) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24DMI443; 40) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24FMF250; 41) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24GMJ484; 42) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24IMF157; 43) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24JMB353; 44) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 25AME014; 45) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 25CME932; 46) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 25DMH878; 47) DYNJ16621C, UDI-DI: 10198459421297(each), 40198459421298(case), Lot Number: 25GMD428; 48) DYNJ16621C, UDI-DI: 10198459421297(each), 40198459421298(case), Lot Number: 25HMC583; 49) DYNJ20546F, UDI-DI: 10193489346084(each), 40193489346085(case), Lot Number: 22IMG976; 50) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21CME149; 51) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21DMD921; 52) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21GMB531; 53) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21HMD738; 54) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21IMD851; 55) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21JMA483; 56) DYNJ20979I, UDI-DI: 1019348… (truncated, 19166 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)