Browse Device Recalls

1,532 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,532 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 1,532 FDA device recalls.

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DateProductReasonClassFirm
Sep 11, 2026 Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A Discrepancy in the shelf-life of a component Class II Medline Industries, LP
Sep 2, 2026 Medline surgical convenience kits labeled as: 1) EAR, Medline product numb... Medical convenience kits were distributed containing cannula components which do not conform to I... Class II Medline Industries, LP
Sep 2, 2026 Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline P... Medical convenience kits were distributed containing cannula components which do not conform to I... Class II Medline Industries, LP
Sep 2, 2026 1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I; 2) ... Medical convenience kits were distributed containing cannula components which do not conform to I... Class II Medline Industries, LP
Sep 2, 2026 Medline surgical convenience kits labeled as: 1) VEIN HARVESTING PACK-LF, ... Medical convenience kits were distributed containing cannula components which do not conform to I... Class II Medline Industries, LP
Sep 2, 2026 Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Produ... Medical convenience kits were distributed containing cannula components which do not conform to I... Class II Medline Industries, LP
Sep 2, 2026 Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF, Medlin... Medical convenience kits were distributed containing cannula components which do not conform to I... Class II Medline Industries, LP
Sep 2, 2026 Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA... Medical convenience kits were distributed containing cannula components which do not conform to I... Class II Medline Industries, LP
Sep 2, 2026 Medline surgical convenience kits labeled as: 1) OPEN HEART CDS, Medline p... Medical convenience kits were distributed containing cannula components which do not conform to I... Class II Medline Industries, LP
Sep 2, 2026 Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK, M... Medical convenience kits were distributed containing cannula components which do not conform to I... Class II Medline Industries, LP
Sep 2, 2026 Medline surgical convenience kits labeled as: VEIN HARVESTING PACK, Medline ... Medical convenience kits were distributed containing cannula components which do not conform to I... Class II Medline Industries, LP
Sep 2, 2026 Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Nu... Medical convenience kits were distributed containing cannula components which do not conform to I... Class II Medline Industries, LP
Sep 2, 2026 Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, M... Medical convenience kits were distributed containing cannula components which do not conform to I... Class II Medline Industries, LP
Aug 31, 2026 Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOP... Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potentia... Class II Medline Industries, LP
Aug 31, 2026 Convenience Kits containing CONMED AirSeal Access Ports HERNANDEZ DAVINCI ... Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potentia... Class II Medline Industries, LP
Aug 31, 2026 Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI ... Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potentia... Class II Medline Industries, LP
Aug 31, 2026 Convenience Kits containing CONMED AirSeal Access Ports KIT ROBOTICS UROLO... Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potentia... Class II Medline Industries, LP
Aug 31, 2026 Convenience Kits containing CONMED AirSeal Access Ports CHN GYN ONCOLOGY ... Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potentia... Class II Medline Industries, LP
Aug 31, 2026 Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOP... Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potentia... Class II Medline Industries, LP
Aug 14, 2026 Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs ... The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the fro... Class II Medline Industries, LP
Aug 14, 2026 Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and ... The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the fro... Class II Medline Industries, LP
Aug 14, 2026 Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand P... Potential fire hazard involving the hand control pendant and associated wiring used with affected... Class I Medline Industries, LP
Aug 14, 2026 Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR1... Potential fire hazard involving the hand control pendant and associated wiring used with affected... Class I Medline Industries, LP
Aug 11, 2026 Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DY... The kits contain certain lots of sterile applicators which may contain fungal contamination that ... Class I Medline Industries, LP
Aug 11, 2026 Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) AC... The kits contain certain lots of sterile applicators which may contain fungal contamination that ... Class I Medline Industries, LP
Aug 11, 2026 Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYND... The kits contain certain lots of sterile applicators which may contain fungal contamination that ... Class I Medline Industries, LP
Aug 11, 2026 Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; ... The kits contain certain lots of sterile applicators which may contain fungal contamination that ... Class I Medline Industries, LP
Aug 11, 2026 Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYND... The kits contain certain lots of sterile applicators which may contain fungal contamination that ... Class I Medline Industries, LP
Aug 11, 2026 Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number:... The kits contain certain lots of sterile applicators which may contain fungal contamination that ... Class I Medline Industries, LP
Aug 11, 2026 Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM... The kits contain certain lots of sterile applicators which may contain fungal contamination that ... Class I Medline Industries, LP
Aug 10, 2026 Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A The kits contain neurological sponges with the potential for unexpected variability of endotoxin ... Class II Medline Industries, LP
Aug 10, 2026 Medline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G; ... The kits contain neurological sponges with the potential for unexpected variability of endotoxin ... Class II Medline Industries, LP
Aug 10, 2026 Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784;... The kits contain neurological sponges with the potential for unexpected variability of endotoxin ... Class II Medline Industries, LP
Aug 10, 2026 Medline convenience kits containing Healthmark Instrument Channel Brushes. ... Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due t... Class II Medline Industries, LP
Aug 10, 2026 Medline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I; ... The kits contain neurological sponges with the potential for unexpected variability of endotoxin ... Class II Medline Industries, LP
Aug 10, 2026 Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197... The kits contain neurological sponges with the potential for unexpected variability of endotoxin ... Class II Medline Industries, LP
Aug 10, 2026 Medline convenience kits containing Healthmark Instrument Channel Brushes. SI... Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due t... Class II Medline Industries, LP
Jul 31, 2026 Convenience kits CATARACT PACK DYNJ59881A Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... Class II Medline Industries, LP
Jul 31, 2026 Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYN... Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... Class II Medline Industries, LP
Jul 31, 2026 Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... Class II Medline Industries, LP
Jul 31, 2026 Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... Class II Medline Industries, LP
Jul 23, 2026 Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.