Browse Device Recalls

119 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 119 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 119 FDA device recalls.

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Date	Product	Reason	Class	Firm
May 25, 2022	a. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam...	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe...	Class III	Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022	STERIS CORP Revital-Ox Resert Hydrogen Peroxide High-Level Disinfectant Revit...	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe...	Class II	Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022	MEDICAL CHEMICAL CORPORATION Total-Fix STOOL COLL KIT, TOTAL FIX PARASITOLOGY...	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe...	Class II	Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022	a. MERIT MEDICAL SYSTEMS Aspira Dressing Kit Aspira Model Number: 4991503. b....	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe...	Class II	Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022	a. Medefil Normal Saline IV Flush Syringe NORMAL SALINE FLUSH, SYR 10ML/12ML ...	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe...	Class II	Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022	a. METREX RESEARCH CORP CaviCide1 DISINFECTANT, CLNR CAVICIDE1 1GL (4/CS) ME...	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe...	Class II	Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022	MAGELLAN DIAGNOSTICS LeadCare II Blood Lead Test Kit Rapid Test Kit LeadCare ...	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe...	Class II	Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022	BECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULT...	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe...	Class II	Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022	CENTURION MEDICAL PRODUCTS, LP Centurion CATH KIT, FML W/LUBE 8FR (50/CS) CNT...	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe...	Class II	Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022	Excelsior Heparin Sodium, Porcine, Preservative Free 100 U / mL Solution Pref...	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe...	Class II	Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022	DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz. Can ...	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe...	Class III	Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022	Absorbent dressings. a. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/...	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe...	Class III	Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022	Perifix LOR Syringe Perifix 8 mL Pouch Luer Lock Tip Without Safety Model ...	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe...	Class II	Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022	MedSource IV Start kit, 8inch Extension Set IV START KIT, W/SITE LOC/8" EX100...	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe...	Class II	Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022	a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent Gen...	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe...	Class II	Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022	SPS MEDICAL SUPPLY Crosstex International Sterilization Roll Sani-Roll Ethyle...	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe...	Class III	Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022	FISHER SCIENTIFIC Fisherbrand SWAB, ROUND BOTTOM CLR (50/PK)FSHSCI Catal...	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe...	Class II	Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022	a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin ...	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe...	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Jun 2, 2021	ANCILLARY ADULT 140-DOSE CONVENIENCE KIT, ITEM #1189482, for the administrati...	Two unsuitable 3mL syringes with conventional needles for vaccine administration included in some...	Class II	Mckesson Medical-Surgical Inc. Corporate Office

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.