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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DateProductReasonClassFirm
May 25, 2022 COOPER SURGICAL Milex PESSARY, RING MILEX INCONT FLEXIBLE SZ6 1 3/4" C... 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 MERIT MEDICAL SYSTEMS Temno Soft Tissue Biopsy Device Temno 14 Gauge 6 cm Len... 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. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ15/8" 50YDS Catal... 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 Dynarex¿ PAD, NAIL POLISH REMOVER (100/BX 10BX/CS) DYNREX Catalog # 1501 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. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hC... 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. McKesson DISINFECTANT, GLUTARALDEHYDE 28DAY (4GL/CS) MGM68, Model Number:... 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 Alere Toxicology TABLET, INSTANT BLUING F/DRUGSCREEN Model Number: 7875 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 Palmero Healthcare, LLC DisCide Ultra Surface Disinfectant Cleaner Quaternary... 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 MERIT MEDICAL SYSTEMS StayFIX FIXATION DEVICE, STAYFIX F/PERCUTAN CATH 5FR-14... 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 a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test... 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 Ultracell Eye Pledget Ultracell 2 X 6 X 1 mm, Sterile Model Number: 40825 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 Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson C... 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. INTEGRA LIFESCIENCE (WND CARE) Shur-Conform Oil Emulsion Oil Emulsion Imp... 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 a. Dynarex DRESSING, UNNA BOOT 3"X10' (12/CS), Catalog # 3453. b. Dynarex... 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 a. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/CS) DYNREX Catalog #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 a. DYNAREX Nice'n Fresh WIPE, BABY WET 6X6.75" (140/CN12CN/CS) Catalog # 131... 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 Cadwell Disposable Ground Electrodes Grounding Pad 1.25 X 1.75 Inch Dimension... 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 B. Braun EVA Gravity Mixing Container 1000 mL Model Number: 2112363 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 DYNAREX Dynarex SWABSTICK, PVP (3/PK 25/BX 10BX/CS) Catalog #1202 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. BECTON DICKINSON BD Vacutainer C&S Preservative Urine Tube TUBE, URINE COL... 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 METREX RESEARCH CORP SPONGE, METRISPONGE W/METRIZYME (25/BX 4BX/CS) ... 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 TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen ... 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. DERMA SCIENCES, INC. NG Strip FASTENER, NASAL TUBE IND WRAP(25/BX), Catalo... 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 FISHER SCIENTIFIC Fisherbrand SWAB TRANS STUARTS DBL 50BX Catalog #1490721 XXX Class II Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 Wetfield Eraser Bipolar Hemostatic Eraser Wet-Field Eraser 23 Gauge Tapered ... 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. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X8"... 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 DYNAREX DynaLube LUBRICATING JELLY, STR 2.7GM (144/BX 12BX/CS) Catalog... 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. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical... 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 NANOSONICS LTD Sonex-HL Ultrasound Probe Disinfectant trophon Sonex-HL 80 mL ... 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. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP GLD 3.5ML PLAS V... 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 MEDLINE INDUSTRIES Centurion IV Securement Kit Model Number: IVSSTK3 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 FISHER SCIENTIFIC Aseptic Control¿ LUBRICATING JELLY PAP TEST 4OZ(12/PK) ... 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. Skin Adhesive McKesson LiquiBand Exceed 0.4 mL Liquid Dome Applicator Tip ... 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 Cooper Surgical PREFILTER, SMOKE EVAC (10/BX)CPRSRG Model Number: 52560. 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 a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack St... 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 a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. ... 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 Medical Monofilament Manufacturing MONOFILIMENT TEST, SENSORY F/FOOT 10GM (40... 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 3M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS)... 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 Sure-Vue PIPETTE, RPR DISPENSING (500/PK) Catalog... 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 Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994 M... 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. DERMARITE INDUSTRIES DermaCol Collagen Dressing DermaCol Without Border Co... 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 Skin markers: a. IZI MEDICAL PRODUCTS LLC Multi-Modality Markers SKIN MARK... 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 DERMARITE INDUSTRIES DermaCol 100 Collagen Powder DermaCol 100 Collagen 1 Gra... 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 MEDLINE INDUSTRIES Medline Plug, Catheter Medline Plastic, with Cover M... 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 B. BRAUN MEDICAL INC. Anesthesia Support Tray SUPPORT TRAY, +EXT SET(10/CS)ST... 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. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit Consult Colorectal Cancer Sc... 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 Drugs of Abuse Tests: a. Wondfo Tdip Drugs of Abuse Test Tdip Single Drug ... 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 GETINGE USA SALES LLC OCEAN Chest Drain System Atrium 2100 mL Model Num... 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 BEAVER-VISITEC INTERNATIONAL, INC. Ultracell WICK, FENSTD PED 7MMX20MM(10/BX)... 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 HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System Fluid ABX Pentra Eching S... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... 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.