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Vehicle Safety

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

Infrastructure

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

3,629 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,629 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 3,629 FDA device recalls, Class I.

Clear
DateProductReasonClassFirm
Apr 27, 2012 Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy ... The specified Trilogy units are being recalled because of the potential for a faulty component in... Class I Respironics, Inc.
Apr 10, 2012 GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-O... GE Healthcare has recently become aware of a potential safety issue due to the interlock slide me... Class I GE Healthcare, LLC
Mar 29, 2012 Fresenius GranuFlo (powder) Acid Concentrate Product Codes: OFD1201-3B, OFD... Risk of Alkalosis with acetate containing dialysis acid concentrates Class I Fresenius Medical Care Holdings, Inc.
Mar 29, 2012 Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-... Risk of Alkalosis with acetate containing dialysis acid concentrates Class I Fresenius Medical Care Holdings, Inc.
Mar 23, 2012 Infusomat(R) Space Pump (US Version) with software version 686G030103 (common... Firm became aware of the potential for breakage of the anti free flow clip catch, located on the ... Class I B. Braun Medical, Inc.
Feb 20, 2012 FLOW-I Anesthesia System The system is intended for use in administrating ... A technical alarm may be generated on the FLOW-i system when using the MAN/AUTO switch to change ... Class I Maquet Cardiovascular Us Sales, Llc
Feb 14, 2012 Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Versio... Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that... Class I Smiths Medical ASD, Inc.
Sep 30, 2011 CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Pro... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing ... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-4316 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Produc... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Produ... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep ... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Pre... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usag... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-8162-R1 Fox Chase Specials Pack containing 2 oz. bottle PVP Prep Solution... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-4975 HSG Tray containing 4 oz. bottle PVP Prep Solution Product Usage:... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiolo... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-8495-R5 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Pro... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-5284 Custom Myelogram Tray containing 2 oz. bottle PVP Prep Solution P... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 12, 2011 Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in ... The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the lab... Class I Engineered Medical Systems,Inc
Jul 9, 2011 Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Pr... Please be aware that this is not a new recall. The firm has taken action; but, due to administrat... Class I First Medical Source LLC
Jul 6, 2011 Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library,... Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow condition... Class I Baxter Healthcare Corporation
Jan 17, 2011 Automated Impella Controller (AIC) with the below product descriptions and co... Retrospective submission for following issues identified: 1. Alarm failures, power-path faults,... Class I Abiomed, Inc.
Jun 22, 2009 OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); I... GE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated... Class I GE OEC Medical Systems, Inc
Feb 22, 2008 OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-ar... Please be aware that this is not a new recall. The firm has taken action; but, due to administra... Class I GE OEC Medical Systems, Inc
Apr 2, 2007 Radiological Image Processing System The system is an aid to locate anatom... The FluoroTrak Spinal Navigation Application on the OEC 9900 EliteNAV could result in an incorrec... Class I GE OEC Medical Systems, Inc
Nov 20, 2006 OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system ... Please be aware that this is not a new recall. The firm has taken action; but, due to administra... Class I GE OEC Medical Systems, Inc
Nov 20, 2006 OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during di... Please be aware that this is not a new recall. The firm has taken action; but, due to administra... Class I GE OEC Medical Systems, Inc
Sep 15, 2006 InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing... Please be aware that this is not a new recall. The firm has taken action; but, due to administra... Class I GE OEC Medical Systems, 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.