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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

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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

3,629 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.

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DateProductReasonClassFirm
May 10, 2023 ICD COBALT VR MRI DF4, Model Number DVPB3D4; Implantable Cardioverter Defibr... There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 10, 2023 CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1; Implantable Car... There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 10, 2023 CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; Implantable Cardio... There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 10, 2023 CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US, Model Number DTBB1Q1; Implantable Card... There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 10, 2023 CRT-D DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1; Implantable Cardiov... There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 10, 2023 CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; Implantable Card... There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 10, 2023 CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; Implantable Cardiover... There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 10, 2023 CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ; Implantable Cardi... There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 10, 2023 CRT-D VIVA QUAD XT GOLD CTD, Model Number DTBA2QQG; Implantable Cardioverter... There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 10, 2023 CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter De... There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 10, 2023 Walnut Wearable Smart Thermometer, intended for continuous chest temperature ... There have been reports of skin burns to children wearing the device. Class I BearCare, Inc.
May 10, 2023 ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; Implantable Cardi... There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 10, 2023 ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G; Implantable C... There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 10, 2023 CRTD DTMB1QQ AMPLIA MRI QUAD US DF4, Model Number DTMB1QQ; Implantable Cardi... There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 10, 2023 CRTD VIVA QUAD XT CUST PARY GOLD, Model Number DTBA1QQPG; Implantable Cardio... There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 10, 2023 CRTD COBALT XT HF QUAD MRI IS4 DF4, Model Number DTPA2QQ; Implantable Cardio... There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 10, 2023 ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; Implantable Cardioverter Def... There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 10, 2023 ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Ca... There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 10, 2023 ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardio... There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 10, 2023 CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; Implantable Cardiover... There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 10, 2023 CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Model Number DTMA1QQ; Implantable Cardi... There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 10, 2023 ICD-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4; Implantable Cardiove... There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 10, 2023 ICD-VR DVBB1D1 EVERA XT IS1/DF1 US, Model Number DVBB1D1; Implantable Cardio... There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 3, 2023 NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Del... Device may experience malfunctions due to misalignment of the check valve in the manifold. If the... Class I NOXBOX LTD
May 1, 2023 Trilogy Evo Universal Ventilator, Model Number DS2000X11B The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventil... Class I Philips Respironics, Inc.
May 1, 2023 Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B,... Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion... Class I Philips Respironics, Inc.
May 1, 2023 Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA220... Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion... Class I Philips Respironics, Inc.
May 1, 2023 Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN210... Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion... Class I Philips Respironics, Inc.
Apr 17, 2023 VentStar Anesthesia WT (P)180, MP00374 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Ventstar Coax, MP03373 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 ID Circuit Basic (P) 180, MP01340 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Watertrap (N) 180, MP00363 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 ID Coax 180, MP03375 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood p... The Impella 5.5 pump experienced a heightened complaint rate for purge leaks. Class I Abiomed, Inc.
Apr 17, 2023 VentStar Watertrap (P) 180 w/oLL, MP00362 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Anesthesia (N) 180, MP00333 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Basic (P)180, MP00351 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Basic (P)250, MP00352 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Anesthesia Circuit Kit Coax 1, MP02730 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Anesthesia Set Coax 180, MP03384 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar breathing bag Set (P) 110, MP00384 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Anesthesia Circuit Kit Coax HEPA, MP17102 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Watertrap (P) 180, MP00361 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Bag Set (N) 110, MP00383 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Coax (P) 150, MP00379 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 VentStar Basic (N) 180, MP00353 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Set2Go Ventilation 12 (A), MP07968 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Anesthesia Circuit Kit Coax 3, MP02732 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Seattle PAP Plus, MP02260 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 17, 2023 Ventstar Coax 180, MP03374 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger 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.