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Recalls affecting Alaska

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

16,247 recalls found

Just announced

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

Business Pill, Branch Manager for Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
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 AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
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. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
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

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
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

Full report
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.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
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.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
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

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
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 SproutsRobust Radish Mix, 5oz Cups

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

Full report
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

MartinaMangoes

Potential contamination with Salmonella

Full report
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

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

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

ALL 50 STATES
Full report

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

Recall #:
98252
Lot/product code:
Model/Catalog Number: KD-401Q-0730; Material REF: 5857030; UDI-DI: 04953170041709; All Lots with a valid expiration date
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

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

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-1520; Material REF: (1) N5411630, (2) N1089910; UDI-DI: (1)04953170380600, (2) N/A; All Lots with a valid expiration date
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

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

ALL 50 STATES
Full report

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

Recall #:
98252
Lot/product code:
Model/Catalog Number: KD-V411M-1530; Material REF: (1) N5411730, (2) N1090010; UDI-DI: (1)04953170380617, (2)N/A; All Lots with a valid expiration date
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43

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) DM1035, UDI-DI: 10193489442755(each), 40193489442756(case), Lot Number: 21BBN221; 2) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 22GBN333; 3) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 22GBF510; 4) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 22EBL039; 5) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 22CBU342; 6) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 21JBJ253; 7) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 21IBJ337; 8) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 21DBD662; 9) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 21ABO838; 10) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 21ABJ003
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

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

ALL 50 STATES
Full report

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

Recall #:
98252
Lot/product code:
Model/Catalog Number: KD-V411M-3030; Material REF: (1) N5411830, (2) N1090310; UDI-DI: (1)04953170184154, (2)N/A; All Lots with a valid expiration date
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0320 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

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

ALL 50 STATES
Full report

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

Recall #:
98252
Lot/product code:
Model/Catalog Number: KD-401Q-0320; Material REF: 5856630; UDI-DI: 04953170041587; All Lots with a valid expiration date
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

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

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

ALL 50 STATES
Full report

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

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

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 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-3020; Material REF: N1090110; 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

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

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

ALL 50 STATES
Full report

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

Recall #:
98252
Lot/product code:
Model/Catalog Number: KD-VC411Q-0725; Material REF: N5424710; 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) 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.

ALL 50 STATES
Full report

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) 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.

ALL 50 STATES
Full report

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) 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
Full report

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 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

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

ALL 50 STATES
Full report

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

Recall #:
98252
Lot/product code:
Model/Catalog Number: KD-V411M-0330; Material REF: (1) N1089530, (2) N1089510, (3) N5411230; UDI-DI: (1) 04953170380563, (2) 04953170380563, (3) 04953170380563; All Lots with a valid expiration date
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

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

ALL 50 STATES
Full report

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

Recall #:
98252
Lot/product code:
Model/Catalog Number: KD-V411M-0720; Material REF: (1) N1089610, (2) N5411330; UDI-DI: (1) 04953170184017, (2) 04953170380570; 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) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 3) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 4) ROBOTIC-LF, Model Number: CDS984543D; 5) ROBOTIC-LF, Model Number: CDS984543F; 6) ROBOTIC-LF, Model Number: CDS984543G; 7) ROBOTIC-LF, Model Number: CDS984543I; 8) GYN CDS, Model Number: CDS984860F; 9) GYN LAP PELVI, Model Number: CDS985423G; 10) GYN KIT, Model Number: DYKM1657A; 11) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL100; 12) KIT ROBOTICS GYN, Model Number: DYKMBNDL109; 13) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116D; 14) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116F; 15) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119; 16) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119A; 17) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168; 18) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168A; 19) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184D; 20) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91; 21) KIT GYN ONCOLOGY, Model Number: DYKMBNDL92; 22) KIT GYN ONCOLOGY, Model Number: DYKMBNDL92A; 23) KIT GYN ABDOMINAL, Model Number: DYKMBNDL92C; 24) KIT GYN LAP, Model Number: DYKMBNDL94; 25) KIT GYN LAP, Model Number: DYKMBNDL94A; 26) KIT GYN LAP, Model Number: DYKMBNDL94C; 27) KIT GYN LAP, Model Number: DYKMBNDL94D; 28) GYN LAPAROSCOPY PACK-LF, Model Number: DYNJ0281948N; 29) PROSTATE ROBOTIC PACK, Model Number: DYNJ0347372F; 30) PROSTATE ROBOTIC PACK, Model Number: DYNJ0347372G; 31) PROSTATE ROBOTIC PACK, Model Number: DYNJ0347372I; 32) HEALTH ALL GYN LAP PACK-LF, Model Number: DYNJ28252G; 33) GYN OPERATIVE LAP PACK-LF, Model Number: DYNJ30005G; 34) OB PACK, Model Number: DYNJ32706B; 35) ROBOTIC UROLOGY-RF, Model Number: DYNJ38844N; 36) ENSEMBLE GYNE LAPAROTOMIE-LF, Model Number: DYNJ47550C; 37) GYN LAP PACK, Model Number: DYNJ47714A; 38) TASC GYN LAP, Model Number: DYNJ49191B; 39) ROBOTIC PACK, Model Number: DYNJ49705K; 40) GYN LAPAROSCOPY PACK, Model Number: DYNJ50348F; 41) NWH GYN LAPAROSCOPY, Model Number: DYNJ50439F; 42) FH LAPAROSCOPIC GYN PK-LF, Model Number: DYNJ51795F; 43) GYN LAPAROSCOPY PACK, Model Number: DYNJ52569B; 44) LAVH PACK, Model Number: DYNJ55862; 45) PK, GEN-LAPAROSCOPY, Model Number: DYNJ57607A; 46) GYN LAPAROSCOPY MRNGSD, Model Number: DYNJ58321A; 47) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079B; 48) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079C; 49) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079D; 50) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079F; 51) GYN DAVINCI PACK, Model Number: DYNJ64266; 52) DAVINCI PACK, Model Number: DYNJ66298D; 53) GYN LAPAROSCOPY, Model Number: DYNJ67269; 54) GENERAL GYN PACK, Model Number: DYNJ68710; 55) LAP GYN PACK, Model Number: DYNJ69419A; 56) LAP GYN PACK, Model Number: DYNJ69419D; 57) GYN LAPAROSCOPY, Model Number: DYNJ81492A; 58) PK, ROBOTIC GYN & GU-ROSE MEDI, Model Number: DYNJ81761A; 59) GYN PACK, Model Number: DYNJ83475A; 60) ROBOTIC XI PACK, Model Number: DYNJ84783; 61) GYN PACK, Model Number: DYNJ86195A; 62) GYN LAPAROSCOPY, Model Number: DYNJ900262A; 63) D&C HYSTEROSCOPY, Model Number: DYNJ901133A; 64) GYN LAPAROSCOPY, Model Number: DYNJ901559J; 65) GYN ENDOSCOPY-LF, Model Number: DYNJ901812J; 66) GYN LITHOTOMY-LF, Model Number: DYNJ902711M; 67) GENERAL ROBOTIC, Model Number: DYNJ905066B; 68) TRINITY C-SEC W/LINEN CDS, Model Number: DYNJ905269G; 69) KIT GYN LAPAROSCOPY RFD, Model Number: DYNJ906322D; 70) GYN LAP LH, Model Number: DYNJ906452C; 71) GYN LAP LH, Model Number: DYNJ906452D; 72) GYN LAP LH, Model Number: DYNJ906452F; 73) FLOYD LITH GYN, Model Number: DYNJ906926B; 74) GYN LAPAROSCOPY-MRMC, Model Number: DYNJ907753F; 75) GYN LAPAROSCOPY-SFMC, Model Number: DYNJ907771C; 76) LAP/GYN ROBOTICS, Model Number: DYNJ908887B; 77) LAP/GYN ROBOTICS, Model Number: DYNJ908887C;

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) CDS982893I, UDI-DI: 10889942208050(each), 40889942208051(case), Lot Number: 24IBO240; 2) CDS983300J, UDI-DI: 10193489425048(each), 40193489425049(case), Lot Number: 21CDB781; 3) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 23CBX440; 4) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 23CBN644; 5) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 23ABC549; 6) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22OBM422; 7) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22KBD152; 8) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22JBC547; 9) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22HBV491; 10) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22GBP114; 11) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22FBV462; 12) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22BBL450; 13) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21VBA272; 14) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21IBM804; 15) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21HBN807; 16) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21GBI171; 17) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21EBA117; 18) CDS984543D, UDI-DI: 10195327072322(each), 40195327072323(case), Lot Number: 22CBC587; 19) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22OBL925; 20) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22KMD619; 21) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22JMA223; 22) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22HMG671; 23) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22HMB259; 24) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22GBD616; 25) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 24BMH483; 26) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23LMA864; 27) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23JMC376; 28) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23IMA629; 29) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23GMH282; 30) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23GMF425; 31) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23FMI171; 32) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23EMI460; 33) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23DMA508; 34) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23CMC582; 35) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23BMD680; 36) CDS984543I, UDI-DI: 10195327637071(each), 40195327637072(case), Lot Number: 24CMH050; 37) CDS984860F, UDI-DI: 10193489261974(each), 40193489261975(case), Lot Number: 21ADB205; 38) CDS985423G, UDI-DI: 10193489319323(each), 40193489319324(case), Lot Number: 21DBV243; 39) CDS985423G, UDI-DI: 10193489319323(each), 40193489319324(case), Lot Number: 21CBH547; 40) CDS985423G, UDI-DI: 10193489319323(each), 40193489319324(case), Lot Number: 21CBH282; 41) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25LBN225; 42) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25HBS386; 43) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25FBS108; 44) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25DBN805; 45) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21JBD206; 46) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21GBP406; 47) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21EBA097; 48) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21BBG514; 49) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21ABI962; 50) DYKMBNDL109, UDI-DI: 10193489478211(each), 40193489478212(case), Lot Number: 21ABW347; 51) DYKMBNDL109, UDI-DI: 10193489478211(each), 40193489478212(case), Lot Number: 21ABO060; 52) DYKMBNDL109, UDI-DI: 10193489478211(each), 40193489478212(case), Lot Number: 21ABM086; 53) DYKMBNDL116D, UDI-DI: 10195327608866(each), 40195327608867(case), Lot Number: 24DBA349; 54) DYKMBNDL116D, UDI-DI: 10195327608866(each), 40195327608867(case), Lot Number: 24CBF889; 55) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24JBB328; 56) DYKMBNDL116F, UDI-DI: 10198459000706(each), 4… (truncated, 30485 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 TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A

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

ALL 50 STATES
Full report

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

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

Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436B; 3) CPNB SETUP TRAY, Model Number: DYNJRA1979; 4) CPNB SETUP TRAY, Model Number: DYNJRA1979A; 5) CPNB SETUP TRAY, Model Number: SAMPA0108

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

ALL 50 STATES
Full report

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

Recall #:
98329
Lot/product code:
1) DYNJ56436A, UDI-DI: 10889942749874(each), 40889942749875(case), Lot Number: 21BMC737; 2) DYNJ56436A, UDI-DI: 10889942749874(each), 40889942749875(case), Lot Number: 21AMB799; 3) DYNJ56436B, UDI-DI: 10193489869569(each), 40193489869560(case), Lot Number: 21DME244; 4) DYNJRA1979, UDI-DI: 10195327186852(each), 40195327186853(case), Lot Number: 22IBU628; 5) DYNJRA1979, UDI-DI: 10195327186852(each), 40195327186853(case), Lot Number: 22GBV936; 6) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 25DME153; 7) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 24KMA261; 8) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 24JMA460; 9) SAMPA0108, UDI-DI: 10195327096861(each), 40195327096862(case), Lot Number: 22NBG086; 10) SAMPA0108, UDI-DI: 10195327096861(each), 40195327096862(case), Lot Number: 22BBD381
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

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

ALL 50 STATES
Full report

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

Recall #:
98252
Lot/product code:
Model/Catalog Number: KD-V411M-0725; Material REF: (1) N1089710, (2) N5411430; UDI-DI: (1) 04953170380587, (2) 04953170380587; All Lots with a valid expiration date
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

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

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

ALL 50 STATES
Full report

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

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

Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005

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

ALL 50 STATES
Full report

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

Recall #:
98642
Lot/product code:
1) DYNJ35363A, UDI-DI: 10884389516461(each), 40884389516462(case), Lot Number: 21BBP020; 2) SPTPCD10005, UDI-DI: 10080196228652(each), 40080196228653(case), Lot Number: 24JBB041
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number:DYNJ905567A

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

ALL 50 STATES
Full report

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

Recall #:
98642
Lot/product code:
1) DYNJ0185290G, UDI-DI: 10193489378054(each), 40193489378055(case), Lot Number: 22LBQ336; 2) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 21EBE777; 3) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 21GBE802; 4) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 21IBH675; 5) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 21KBA253; 6) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 21KBR457; 7) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 22CBY841; 8) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 22HBF686; 9) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 22HBM263; 10) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 22HBP453; 11) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 22LBC300; 12) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 22NBF780; 13) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 23CBQ546; 14) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 23EBH550; 15) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 23FBG152; 16) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 23FBL644; 17) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 23HBG596; 18) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 23KBI089; 19) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 24BBN429; 20) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 24GBT983; 21) DYNJ905567A, UDI-DI: 10193489348927(each), 40193489348928(case), Lot Number: 24HBP446
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number:DYNJ56436B; 3) SCC RF PAIN MGMT, Model Number:DYNJ56436C; 4) CPNB SETUP TRAY, Model Number:DYNJRA1979; 5) CPNB SETUP TRAY, Model Number:DYNJRA1979A; 6) CPNB SETUP TRAY, Model Number:DYNJRA1979B; 7) VARITHENA TRAY 2, Model Number:DYNJRA2608; 8) CPNB SETUP TRAY, Model Number:SAMPA0108

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

ALL 50 STATES
Full report

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

Recall #:
98642
Lot/product code:
1) DYNJ56436A, UDI-DI: 10889942749874(each), 40889942749875(case), Lot Number: 21AMB799; 2) DYNJ56436A, UDI-DI: 10889942749874(each), 40889942749875(case), Lot Number: 21BMC737; 3) DYNJ56436B, UDI-DI: 10193489869569(each), 40193489869560(case), Lot Number: 21DME244; 4) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23AMG574; 5) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23DMA829; 6) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23DMI776; 7) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23EMH095; 8) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23FMI704; 9) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23HMC628; 10) DYNJ56436C, UDI-DI: 10195327059668(each), 40195327059669(case), Lot Number: 23IMC652; 11) DYNJRA1979, UDI-DI: 10195327186852(each), 40195327186853(case), Lot Number: 22GBV936; 12) DYNJRA1979, UDI-DI: 10195327186852(each), 40195327186853(case), Lot Number: 22IBU628; 13) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 24IMG516; 14) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 24JMA460; 15) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 24KMA261; 16) DYNJRA1979A, UDI-DI: 10195327649258(each), 40195327649259(case), Lot Number: 25DME153; 17) DYNJRA1979B, UDI-DI: 10198459371950(each), 40198459371951(case), Lot Number: 25FBG333; 18) DYNJRA2608, UDI-DI: 10198459331640(each), 40198459331641(case), Lot Number: 25ELB099; 19) SAMPA0108, UDI-DI: 10195327096861(each), 40195327096862(case), Lot Number: 22BBD381; 20) SAMPA0108, UDI-DI: 10195327096861(each), 40195327096862(case), Lot Number: 22NBG086
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS985094F; 3) INTRAVASOR CATH KIT, Model Number:DYK1060193I; 4) KIT SURG ONC LAP DIAG/CV CATH, Model Number:DYKMBNDL153; 5) KIT ACES INSERT PERCUTANEOUS T, Model Number:DYKMBNDL4A; 6) KIT ACES INSERT PERCUTANEOUS T, Model Number:DYKMBNDL4B; 7) VEIN PROCEDURE KIT, Model Number:DYNDA2076C; 8) CARDIAC CATH PACK-LF, Model Number:DYNJ0150605AC; 9) CARDIAC CATH PACK-LF, Model Number:DYNJ0368386D; 10) CATH LAB PACK-LF, Model Number:DYNJ0648473Y; 11) NBMC CATH PACK-LF, Model Number:DYNJ0803367I; 12) RADIOLOGY PACK-LF, Model Number:DYNJ0928124C; 13) ANGIO PACK-LF, Model Number:DYNJ0954970I; 14) SPECIALS TRAY RADIOLOGY, Model Number:DYNJ16803D; 15) CARDIAC CATH PACK, Model Number:DYNJ19946M; 16) CATH LAB PACK, Model Number:DYNJ30955I; 17) CATH LAB PACK, Model Number:DYNJ31773K; 18) CATH PACK-LF, Model Number:DYNJ33061D; 19) DB CCL OAKWOOD PACK-LF, Model Number:DYNJ33620D; 20) CARDIAC CATH PACK MRH-LF, Model Number:DYNJ35300M; 21) CATH LAB PK, Model Number:DYNJ35643C; 22) CARDIAC CATH PACK-LF, Model Number:DYNJ39066B; 23) ANGIOGRAPHY PACK, Model Number:DYNJ42134G; 24) CATH PACK-LF, Model Number:DYNJ43101C; 25) OR ANGIO PACK-LF, Model Number:DYNJ43415D; 26) OR ANGIO PACK-LF, Model Number:DYNJ43415F; 27) ANGIOPLASTY PACK, Model Number:DYNJ44700J; 28) ANGIOGRAPHY DRAPE PACK, Model Number:DYNJ44850J; 29) RADIOLOGICAL PACK, Model Number:DYNJ44889O; 30) CARDIAC CATH PACK, Model Number:DYNJ47370B; 31) ANGIOGRAPHY PACK, Model Number:DYNJ53129D; 32) ANGIOGRAPHY DRAPE PACK, Model Number:DYNJ56772G; 33) DR. MOHINDRA PACK, Model Number:DYNJ57602G; 34) NE ENDO VASCULAR PACK, Model Number:DYNJ57940B; 35) CARDIAC CATH PACK - Q1, Model Number:DYNJ58048C; 36) OR ANGIO, Model Number:DYNJ59931B; 37) LPCH PERRY CATH PACK, Model Number:DYNJ67378C; 38) HOSPITAL REGIONAL DE CONCEPCIO, Model Number:DYNJ67918A; 39) CATH LAB PACK, Model Number:DYNJ68633; 40) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197B; 41) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197C; 42) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197D; 43) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197F; 44) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197G; 45) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197I; 46) BASIC CARDIAC CATH PACK, Model Number:DYNJ81593B; 47) CATH LAB PACK, Model Number:DYNJ83073; 48) UMC EL PASO CATH PACK, Model Number:DYNJ83089; 49) DR. MOHINDRA PACK, Model Number:DYNJ83819A; 50) VZ VAS/ANG PACK, Model Number:DYNJ83981; 51) WCPN CARDIOLOGY PACK, Model Number:DYNJ84539; 52) CATH LAB, Model Number:DYNJ85511; 53) CATH LAB, Model Number:DYNJ85511A; 54) ANGIOGRAPHY DRAPE PACK, Model Number:DYNJT1520K; 55) CVC BUNDLE KIT, Model Number:ECVC6225A; 56) CVC 3L 7F 20CM VANTEX, Model Number:ECVC7265A; 57) ANGIOGRAPHY TRAY, Model Number:MNS9130

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

ALL 50 STATES
Full report

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

Recall #:
98642
Lot/product code:
1) 00-401824AB, UDI-DI: 10198459089169(each), 40198459089160(case), Lot Number: 24IBQ637; 2) 00-401824AB, UDI-DI: 10198459089169(each), 40198459089160(case), Lot Number: 24KBF279; 3) 00-401824AB, UDI-DI: 10198459089169(each), 40198459089160(case), Lot Number: 24LBF132; 4) 00-401824AB, UDI-DI: 10198459089169(each), 40198459089160(case), Lot Number: 25CBJ807; 5) 00-401824AB, UDI-DI: 10198459089169(each), 40198459089160(case), Lot Number: 25DBO471; 6) 00-401824AB, UDI-DI: 10198459089169(each), 40198459089160(case), Lot Number: 25GBK506; 7) CDS985094F, UDI-DI: 10195327657642(each), 40195327657643(case), Lot Number: 25AMG933; 8) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 22KBQ113; 9) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 23ABU376; 10) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 23DBD193; 11) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 23GBT819; 12) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 23HBQ238; 13) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 23IBR569; 14) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 23KBH770; 15) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 23LBO849; 16) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 24ABW181; 17) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 24EBM208; 18) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 24GBA239; 19) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 24IBE619; 20) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 24JBA719; 21) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 24KBJ312; 22) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 24LBM892; 23) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 25BBK679; 24) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 25CBB540; 25) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 25DBA780; 26) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 25FBR530; 27) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 25GBQ911; 28) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 21ABI976; 29) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 21BBG516; 30) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 21LBJ748; 31) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 22ABO093; 32) DYKMBNDL4A, UDI-DI: 10193489904512(each), 40193489904513(case), Lot Number: 21GLA287; 33) DYKMBNDL4A, UDI-DI: 10193489904512(each), 40193489904513(case), Lot Number: 21GLA930; 34) DYKMBNDL4A, UDI-DI: 10193489904512(each), 40193489904513(case), Lot Number: 21KLA100; 35) DYKMBNDL4A, UDI-DI: 10193489904512(each), 40193489904513(case), Lot Number: 22ALA279; 36) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 22HLB260; 37) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23BLA583; 38) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23GLA176; 39) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23GLA710; 40) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23HLA316; 41) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23ILA268; 42) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23JLA979; 43) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23KLA402; 44) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 24CLA777; 45) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 24FLA816; 46) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 25ALA014; 47) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 25ELA738; 48) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 25HLA757; 49) DYNDA2076C, UDI-DI: 10198459001208(each), 40198459001209(case), Lot Number: 24HMD928; 50) DYNDA2076C, UDI-DI: 10198459001208(each), 40198459001209(case), Lot Number: 24KMC111; 51) DYNDA2076C, UDI-DI: 10198459001208(each), 40198459001209(case), Lot Number: 24LMB205; 52) DYNJ0150605AC, UDI-DI: 10198459106422(each), 40198459106423(case), Lot Number: 24IMB736; 53) DYNJ0368386D, UDI-DI: 10889942060245(each), 40889942060246(case), Lot Number: 23BMB501; 54) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24GBT979; 55) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24HBQ060; 56) DYNJ0648473Y, UD… (truncated, 25153 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2026

Medline Convenience Kits: 1) PICC LINE TRAY, Model Number:00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268B; 3) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268C; 4) TRAY 6 CENTRAL LINE A, Model Number:ACC010487; 5) PEDS PICC INSERTION TRAY, Model Number:CVI3650; 6) LINE ATTIRE KIT, Model Number:DYKM2170; 7) PK BNDL CENT LINE PROTECT KIT, Model Number:DYKM2274; 8) KIT SURG ONC LAP DIAG/PORT INS, Model Number:DYKMBNDL153C; 9) KIT SURG ONC INSERT CENT.VENOU, Model Number:DYKMBNDL43A; 10) KIT SURG ONC PORT INSERTION, Model Number:DYKMBNDL43C; 11) VEIN PROCEDURE KIT, Model Number:DYNDA2076B; 12) VEIN PROCEDURE KIT, Model Number:DYNDA2076D; 13) VEIN PROCEDURE KIT, Model Number:DYNDA2076F; 14) PLACENTA KIT, Model Number:DYNDA2322B; 15) NICU CENTRAL LINE TRAY, Model Number:DYNDC2407A; 16) NICU CENTRAL LINE TRAY, Model Number:DYNDC2407B; 17) PICC LINE TRAY, Model Number:DYNJ40500A; 18) VENOUS ACCESS PACK, Model Number:DYNJ42694C; 19) AV FISTULA CREATION PACK-LF, Model Number:DYNJ53427B; 20) PICC LINE, Model Number:DYNJ55546D; 21) PICC TRAY, Model Number:DYNJ63199A; 22) PICC KIT 4F SL PL MAX BARRIER, Model Number:DYNJ70141MB; 23) PICC KIT 5F DL PL MB, Model Number:DYNJ70152MB; 24) VEIN PACK, Model Number:DYNJ84239; 25) NEXTON PACK, Model Number:DYNJ88152; 26) PICC INSERTION TRAY W/O CATH, Model Number:PICCNC0004

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

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Full report

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

Recall #:
98642
Lot/product code:
1) 00-401993O, UDI-DI: 10195327517366(each), 40195327517367(case), Lot Number: 23KBH528; 2) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21BDB379; 3) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21CDB078; 4) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21IDC222; 5) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21JDB458; 6) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22ADC105; 7) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22BDA862; 8) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22CDC433; 9) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22DDA763; 10) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22FDB218; 11) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23BDB271; 12) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23DDA455; 13) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23DDB175; 14) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23FDC048; 15) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23GDB567; 16) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23IDA297; 17) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 24DDA188; 18) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24HDB961; 19) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24IDB060; 20) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24JDB298; 21) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24KDA478; 22) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 25DDB786; 23) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 25EDA196; 24) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 21CDC422; 25) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 21LDB744; 26) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 22BDB354; 27) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23EDB085; 28) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23FDB587; 29) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDA369; 30) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDB672; 31) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDB680; 32) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23HDA348; 33) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25ADB553; 34) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25BDA733; 35) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25BDB580; 36) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25HDA748; 37) CVI3650, UDI-DI: 10653160256397(each), 40653160256398(case), Lot Number: 22EBO541; 38) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 22IBN124; 39) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 23ABC583; 40) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 23BBA792; 41) DYKM2274, UDI-DI: 10198459278884(each), 40198459278885(case), Lot Number: 25HBK806; 42) DYKMBNDL153C, UDI-DI: 10198459000430(each), 40198459000431(case), Lot Number: 24DBR907; 43) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 22IBK412; 44) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 22IBM493; 45) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case).Lot Number: 23ABK335; 46) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 23BBS866; 47) DYKMBNDL43C, UDI-DI: 10198459000553(each), 40198459000554(case), Lot Number: 24DBS686; 48) DYNDA2076B, UDI-DI: 10195327572020(each), 40195327572021(case), Lot Number: 24ABI534; 49) DYNDA2076D, UDI-DI: 10198459216060(each), 40198459216061(case), Lot Number: 24LMH364; 50) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25FMF582; 51) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25HMH651; 52) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25IMA505; 53) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25KMH542; 54) DYNDA2322B, UDI-DI: 10195327299774(each), 40195327299775(case), Lot Number: 23FBW064; 55) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21ABI600; 56) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Numbe… (truncated, 8610 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)