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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
Oct 8, 2014 Cysto Tur Pack, catalog #900-2899 Used by medical staff to perform patient... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Extremity Arm Pack, catalog #900-2438 Used by medical staff to perform pat... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Minor Laparotomy Pack, Catalog number 900-450. Used by medical staff to pe... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Peri Gyn Pack, Catalog number 900-1061. Used by medical staff to perform p... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Skin Staple Removal, Catalog number 900-782. Used by medical staff to perf... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Angiography Pack, Catalog number 900-1488. Used by medical staff to perfor... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Wound Closure Tray I, Catalog number 900-063. Used by medical staff to per... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Endovenous Custom Pack, Catalog number 900-1937. Used by medical staff to ... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 O.R. Towels, Catalog number 900-629. Used by medical staff to perform pati... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 OB Pack, Catalog number 900-1717. Used by medical staff to perform patient... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 OB Pack, catalog #900-254 Used by medical staff to perform patient care pr... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Lithotomy Pack, catalog #900-2167 Used by medical staff to perform patient... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Peri Gyn Pack, Catalog number 900-1091. Used by medical staff to perform p... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Cysto Tur Pack, Catalog number 900-430 Used by medical staff to perform p... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Femoral Pack, catalog #900-2164 Used by medical staff to perform patient c... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Laparoscopy Pack, Catalog number 900-3178. Used by medical staff to perfor... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Cesarean Pack, Catalog number 900-403. Used by medical staff to perform pa... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Laparotomy Pack III (4), catalog #900-2492 Used by medical staff to perfor... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Sep 16, 2014 ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8... Product sterility is not assured Class II Bio-Detek, Inc.
Sep 16, 2014 ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012... Product sterility is not assured Class II Bio-Detek, Inc.
Sep 16, 2014 ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwi... Product sterility is not assured Class II Bio-Detek, Inc.
Sep 16, 2014 ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwi... Product sterility is not assured Class II Bio-Detek, Inc.
Sep 3, 2014 Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB... Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the... Class II Teleflex Medical
Sep 3, 2014 Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 102... Possibility that the nebulizer adaptor packaging may have open or weak seals which may affect the... Class II Teleflex Medical
Aug 27, 2014 GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS... Due to an anomaly in the packaging process, it is possible that a defective seal could be present... Class II Gyrus Medical, Inc
Aug 26, 2014 ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part num... Sterility of device is not assured Class II Bio-Detek, Inc.
Aug 26, 2014 ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012... Sterility of device is not assured Class II Bio-Detek, Inc.
Aug 26, 2014 ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadw... Sterility of device is not assured Class II Bio-Detek, Inc.
Aug 25, 2014 BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 4F-55 cm, UPN... NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... Class II Navilyst Medical, Inc
Aug 25, 2014 PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve... NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... Class II Navilyst Medical, Inc
Aug 25, 2014 PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F... NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... Class II Navilyst Medical, Inc
Aug 25, 2014 PICC Convenience Kit with Accessories, BioFlo Hybrid PICC, 6F-55 cm TRIPLE LU... NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... Class II Navilyst Medical, Inc
Aug 25, 2014 BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN... NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... Class II Navilyst Medical, Inc
Aug 25, 2014 PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve... NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... Class II Navilyst Medical, Inc
Aug 25, 2014 PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve... NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... Class II Navilyst Medical, Inc
Aug 25, 2014 BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier ... NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... Class II Navilyst Medical, Inc
Aug 25, 2014 PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve... NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... Class II Navilyst Medical, Inc
Aug 25, 2014 BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN... NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... Class II Navilyst Medical, Inc
Aug 25, 2014 PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve... NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... Class II Navilyst Medical, Inc
Aug 25, 2014 PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F... NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it ... Class II Navilyst Medical, Inc
Aug 13, 2014 Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; S... Internal testing had identified a potential breach to the sterile barrier that may impact the ste... Class II Volcano Corporation
Aug 8, 2014 BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which co... Class II Bard Access Systems
Aug 8, 2014 BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which co... Class II Bard Access Systems
Aug 8, 2014 BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which co... Class II Bard Access Systems
Aug 8, 2014 BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which co... Class II Bard Access Systems
Aug 8, 2014 BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which co... Class II Bard Access Systems
Aug 6, 2014 Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Me... The component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline F... Class II Arrow International Inc
Aug 5, 2014 CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes a... ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit pa... Class II ICU Medical, Inc.
Aug 5, 2014 Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefil... ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit pa... Class II ICU Medical, Inc.
Aug 5, 2014 Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefill... ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit pa... Class II ICU Medical, 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.