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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

3,164 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,164 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 3,164 FDA device recalls.

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DateProductReasonClassFirm
May 9, 2017 Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
May 9, 2017 Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+a... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
May 9, 2017 1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pre... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
May 9, 2017 1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
May 9, 2017 Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
May 9, 2017 1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Fea... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
Apr 21, 2017 Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. Sterile, Rx Only. For Si... 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 Round Drain, 19FR W/15FR Trocar. Sterile, Rx ... 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, 3/4 Ducts. Sterile, Rx Only. For Si... 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 W/Trocar. Sterile, Rx Only. For... 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 Round Drain, 10FR W/Trocar. Sterile, Rx Only.... 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 Full W/Trocar. Sterile, Rx Only. For ... 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, 10mm, Full Ducts W/15FR Trocar. ... 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 Round Drain, 10FR W/10FR Trocar. Sterile, Rx ... 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, 10FR. 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 Round Drain, 15FR W/15FR Trocar. Sterile, Rx ... 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 Round Drain, 10FR W/Trocar. Sterile, Rx Only.... 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 Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx... 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 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.

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.