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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

3,664 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,664 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 3,664 FDA device recalls, Class I.

Clear
DateProductReasonClassFirm
May 10, 2023 CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1; 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 DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1; Implantable Cardiovert... 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 DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; Implantable ... 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 DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4; 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 CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; Implantable Cardioverte... 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-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; 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 DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; 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 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 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.
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 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 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.
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 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 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 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 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 (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 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 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 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 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 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 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 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 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 Ventstar Coax 180, MP03374 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 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 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 Coax, MP03373 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 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 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 Ventstar Coax 230, MP03376 Glued connections of the breathing circuit can become loose before or during ventilation resultin... Class I Draeger Medical, Inc.
Apr 11, 2023 StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit... During non-axial/some axial exams, software anomalies occur during procedures affecting depth gau... Class I Medtronic Navigation, Inc.
Apr 11, 2023 StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/... In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection ... Class I Medtronic Navigation, Inc.
Apr 7, 2023 Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part ... There were reports from customers that the tracheostomy in the sets and trays is not making a sec... Class I Cook Incorporated
Apr 7, 2023 Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part... There were reports from customers that the tracheostomy in the sets and trays is not making a sec... Class I Cook Incorporated
Mar 31, 2023 Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 9... The liquid buffer component in the affected test kit lots was determined to have bacterial contam... Class I SD Biosensor, Inc.
Mar 28, 2023 Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control dri... Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result... Class I Percussionaire Corporation
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: ... A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy ... Class I Covidien
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp
Mar 24, 2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath... Class I Cordis US Corp

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.