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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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Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

3,179 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,179 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 3,179 FDA device recalls.

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DateProductReasonClassFirm
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
May 22, 2017 TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE There is a potential risk of puncture to the packaging material which can compromise the devices ... Class II Somatex Medical Technologies GmbH
May 22, 2017 Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath,... Lack of sterility assurance. Class II Creganna Medical Devices
May 22, 2017 Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, ... Lack of sterility assurance. Class II Creganna Medical Devices
May 22, 2017 Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath,... Lack of sterility assurance. Class II Creganna Medical Devices
May 22, 2017 Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath,... Lack of sterility assurance. Class II Creganna Medical Devices
May 17, 2017 QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dres... Packaging breach may compromise sterility Class II Z-Medica, LLC
May 9, 2017 Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
May 9, 2017 1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for H... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
May 9, 2017 1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blu... Arrow International is recalling the affected product because the packaging may not be completely... Class II Arrow International Inc
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

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.