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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

3,096 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,096 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 3,096 FDA device recalls.

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DateProductReasonClassFirm
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Round Drain, 19FR. Sterile, Rx Only. For Sin... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Round Drain, 7FR. Sterile, Rx Only. For Single Use On... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Round Drain, 15FR. Sterile, Rx Only. For Single Use O... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use O... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Flat Drain. Sterile, Rx Only. For Single Use... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For S... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt PVC Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single U... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts. Sterile, Rx Only. For Sin... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 13, 2017 Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gent... Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek pac... Class II Zimmer Biomet, Inc.
Apr 12, 2017 Cardiac Insulation Pad, OPEN HEART CDS Complete delivery System (CDS) # CDS984746C was assembled using a non-sterile cardiac insulation ... Class II Medline Industries, Inc.
Apr 10, 2017 CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units eac... B. Braun is voluntarily recalling 13 lots of CytoGuard Closed Luer Connector due to a potential f... Class II B Braun Medical Inc
Apr 3, 2017 Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI ... Product sterility compromised due to breach in sterile barrier package Class II Mederi Therapeutics, Inc
Mar 3, 2017 Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm),... Product sterility is compromised due to breach of sterile barrier Class II Covidien LLC
Mar 3, 2017 Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curi... Product sterility is compromised due to breach of sterile barrier Class II Covidien LLC
Mar 3, 2017 Covidien Curity Eye Pad Oval, 1-5/8 x 2-5/8 (4.2 cm x 6.7 cm), Sterile It... Product sterility is compromised due to breach of sterile barrier Class II Covidien LLC
Mar 3, 2017 Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code:... Product sterility is compromised due to breach of sterile barrier Class II Covidien LLC
Mar 3, 2017 Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device t... Product sterility is compromised due to breach of sterile barrier Class II Covidien LLC
Mar 3, 2017 Panta Nail, Rx only, Sterile, Voluntary recall/Removal of Panta and Panta XI Nails because there may be the potential that the ... Class II Integra LifeSciences Corp.
Mar 3, 2017 Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device t... Product sterility is compromised due to breach of sterile barrier Class II Covidien LLC
Mar 3, 2017 Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code:... Product sterility is compromised due to breach of sterile barrier Class II Covidien LLC
Jan 31, 2017 Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Ster... Product sterility compromised due to breach of sterile barrier Class II Degania Silicone, Ltd.
Jan 23, 2017 Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-... Sterility compromised due to breach in sterile barrier Class II Covidien LLC
Jan 23, 2017 Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphe... Sterility compromised due to breach in sterile barrier Class II Covidien LLC
Jan 18, 2017 BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for... The recalling firm received a complaint from one of their customers of a potential defect in the ... Class II Argon Medical Devices, Inc
Jan 18, 2017 T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEED... The recalling firm received a complaint from one of their customers of a potential defect in the ... Class II Argon Medical Devices, Inc
Jan 18, 2017 HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or... The recalling firm received a complaint from one of their customers of a potential defect in the ... Class II Argon Medical Devices, Inc
Jan 11, 2017 Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, pa... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Stem Pack, part number AMS5166 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Hernia Pack, part number AMS3859 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Breast Recon Pack, part number AMS5698 Breast Recon Pack, part number AMS5698(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Bayview Abdominoplasty Pack, part number 009079-1 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Lower Extremity Pack, part number AMS4669 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Lap Gallbladder Pack, part number AMS3707 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Facial Plastic Pack, part number AMS3327(C The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Universal Pack, part number AMS2036 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Morris Lap Pack, part number PSS3199(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Angio Pack, part number AMS6711 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Brow Pack, part number PSS1785(C The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Extremity Pack-N Brunswick, part number PSS1866(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Plastic General Pack, part number AMS4215 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Facial Pack , part number AMS6501 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Dr. Landi EVLT Pack, part number AMS1483(E Dr. Landi EVLT Pack, part number ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Dr Bragg Vein Tray - RX, part number 007912-8 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Plastic Kit, part number CMP1084(C The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Open Procedure Pack, part number AMS4596 Open Procedure Pack, part number AM... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Percutaneous Entry Kit, part number TVS4022(D Percutaneous Entry Kit , part ... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Abdominoplasty Pack, Part numbers AMS3326(B, AMS4381, and AMS4381(B. The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Basic Pack (1185), part number AMS6560 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Lumbar Laminectomy Pack, part number AMS2501 Lumbar Laminectomy Pack, part n... The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.
Jan 11, 2017 Set Up Pack, part number PSS3574(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) ... Class II Windstone Medical Packaging, Inc.

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.