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Browse Device Recalls

319 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 319 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 319 FDA device recalls.

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DateProductReasonClassFirm
Jul 11, 2024 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Produ... Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential ... Class II Medtronic Inc.
Apr 16, 2024 EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defib... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibri... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardi... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibri... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defib... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardiover... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardiover... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardi... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 Product not distributed in the US. Implantable Cardioverter Defibrillators: ... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardiover... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibri... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibri... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibr... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibri... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibri... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibr... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibri... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Def... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Def... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardiove... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibr... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Apr 16, 2024 EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defib... Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in m... Class II Medtronic Inc.
Feb 16, 2024 Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090;... There is a potential for sterile package breach. Class II Medtronic Inc.
Dec 7, 2023 Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product num... During internal review of Polaris battery assembly data from the HiPot operation, a test systems ... Class II Medtronic Inc.
Nov 20, 2023 Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-... Seal defects could compromise the ability of the product packaging to maintain sterility. Class II Medtronic Inc.
Nov 3, 2023 ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor It may create the potential for amplified noise and/or overall signal reduction of the ICM, which... Class II Medtronic Inc.
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 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 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 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 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-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 CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ; 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 DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1; 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 DTBC2Q1 BRAVA QUAD IS4/DF1 INTL, Model Number DTBC2Q1; 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 ICD COBALT XT VR MRI DF4, Model Number DVPA2D4; 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 VR MRI DF4, Model Number DVPC3D4; Implantable Cardioverter Defibri... 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 EVERA XT DR GOLD CTD, Model Number DDBB1D4G; 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 COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1; 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 CRTD DTPA2D1PX COBALT XT HF QUAD OUS, Model Number DTPA2D1PX; 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 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 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 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 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 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 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 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 ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; 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...

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.