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Browse Device Recalls

3,428 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,428 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 3,428 FDA device recalls — Class I.

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DateProductReasonClassFirm
May 10, 2023 CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; 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 CRTD COBALT HF QUAD MRI IS4 DF1, Model Number DTPB2Q1 ; 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 DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; 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 CROME DR MRI IS1 DF4, Model Number DDPC3D4; 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 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 VISIA AF S US/OUS DF4, Model Number DVAC3D4; 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 ICD COBALT XT HF QUAD OUS, Model Number DTPA2QQG; Implantable Cardioverter D... 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 ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; 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 ICD-VR DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4; 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 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-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; 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 ICD COBALT DR MRI IS1 DF1, Model Number DDPB3D1; 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 ICD COBALT VR MRI IS1 DF1, Model Number DVPB3D1; 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 CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; 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 ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; 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 CROME DR MRI IS1 DF1, Model Number DDPC3D1; 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 CRTD DTPA2D1G COBALT XT HF QUAD OUS, Model Number DTPA2D1G; 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 ICD COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1; 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 CRT-D DTBB2Q1 VIVA QUAD S IS4/DF1 INTL, Model Number DTBB2Q1; 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 CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4; 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 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 CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; 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 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, 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 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 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 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 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 230, MP03376 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 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 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 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 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 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 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 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 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 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 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 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 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 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 Anesthesia (N) 180, MP00333 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.