Browse Device Recalls

1,680 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,680 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 1,680 FDA device recalls.

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DateProductReasonClassFirm
Sep 26, 2023 Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized... Specific serial numbers of GraftonTM DBM product due to the potential that a step during the insp... Class II Medtronic Sofamor Danek USA Inc
Sep 26, 2023 Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T... Specific serial numbers of GraftonTM DBM product due to the potential that a step during the insp... Class II Medtronic Sofamor Danek USA Inc
Sep 26, 2023 Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demin... Specific serial numbers of GraftonTM DBM product due to the potential that a step during the insp... Class II Medtronic Sofamor Danek USA Inc
Sep 26, 2023 Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d)... Specific serial numbers of GraftonTM DBM product due to the potential that a step during the insp... Class II Medtronic Sofamor Danek USA Inc
Sep 26, 2023 Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone M... Specific serial numbers of GraftonTM DBM product due to the potential that a step during the insp... Class II Medtronic Sofamor Danek USA Inc
Sep 26, 2023 Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix Specific serial numbers of GraftonTM DBM product due to the potential that a step during the insp... Class II Medtronic Sofamor Danek USA Inc
Jul 31, 2023 Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, De... The incorrect product labeling was applied to the product indicating the wrong size of product. Class II Medtronic Sofamor Danek USA Inc
Jul 25, 2023 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluorosc... Ground cable installed incorrectly. Class II Medtronic Navigation, Inc.-Littleton
Jul 12, 2023 CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K Incorrect Laser Marking - Solera Awl Tip Tap Class II Medtronic Sofamor Danek USA, Inc
Jul 6, 2023 Medtronic InterStim Ground Pad REF 041826 Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with... Class II Medtronic Neuromodulation
Jun 28, 2023 Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink I... Product labeling contains incorrect expiration date Class II Medtronic Neurosurgery
Jun 21, 2023 A901 Communication Manager Application, used in conjunction with the A710 Cli... When an update to the A710 Clinician Programmer software application for the Intellis Neurostimul... Class II Medtronic Neuromodulation
Jun 13, 2023 Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; ... Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-pro... Class II Medtronic Neurosurgery
Jun 6, 2023 Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... There is the potential for out of specification device geometries. widths, lengths, heights, and... Class II Medtronic Sofamor Danek USA Inc
Jun 6, 2023 Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... There is the potential for out of specification device geometries. widths, lengths, heights, and... Class II Medtronic Sofamor Danek USA Inc
Jun 6, 2023 Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, ... There is the potential for out of specification device geometries. widths, lengths, heights, and... Class II Medtronic Sofamor Danek USA Inc
Jun 6, 2023 Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... There is the potential for out of specification device geometries. widths, lengths, heights, and... Class II Medtronic Sofamor Danek USA Inc
Jun 6, 2023 Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... There is the potential for out of specification device geometries. widths, lengths, heights, and... Class II Medtronic Sofamor Danek USA Inc
Jun 6, 2023 Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal cho... A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unre... Class II Medtronic Neuromodulation
Jun 6, 2023 Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... There is the potential for out of specification device geometries. widths, lengths, heights, and... Class II Medtronic Sofamor Danek USA Inc
Jun 6, 2023 Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Stand... There is the potential for out of specification device geometries. widths, lengths, heights, and... Class II Medtronic Sofamor Danek USA Inc
May 22, 2023 Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuratio... Class II Covidien, LLC
May 16, 2023 HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech,... Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monito... Class II Heartware, 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...
May 10, 2023 ICD-VR VISIA AF XT OUS IS1/DF1, Model Number DVAB2D1; 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 VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; 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 DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; 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-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; 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-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; 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.