Browse Device Recalls

1,708 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,708 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 1,708 FDA device recalls.

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DateProductReasonClassFirm
May 10, 2023 ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; 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 DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4; 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 DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; 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 DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; 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 CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; 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 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 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 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-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 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 CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; 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-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; 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 DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; 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 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 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 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 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 CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; 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 CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; 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 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 ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; 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...
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 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.
Mar 17, 2023 Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler... Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers wit... Class II Medtronic Neuromodulation
Mar 1, 2023 Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K),... Medtronic was made aware of a supplier calibration issue during the contract sterilization proces... Class II Covidien, LP
Mar 1, 2023 Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT ... Medtronic was made aware of a supplier calibration issue during the contract sterilization proces... Class II Covidien, LP
Mar 1, 2023 Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURG... Medtronic was made aware of a supplier calibration issue during the contract sterilization proces... Class II Covidien, LP
Mar 1, 2023 Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sl... Medtronic was made aware of a supplier calibration issue during the contract sterilization proces... Class II Covidien, LP
Feb 16, 2023 INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXI... Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 ba... Class II Medtronic Sofamor Danek USA Inc
Feb 16, 2023 INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.... Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 ba... Class II Medtronic Sofamor Danek USA Inc
Feb 16, 2023 INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.... Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 ba... Class II Medtronic Sofamor Danek USA Inc
Feb 16, 2023 INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.... Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 ba... Class II Medtronic Sofamor Danek USA Inc
Feb 16, 2023 INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.... Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 ba... Class II Medtronic Sofamor Danek USA Inc
Feb 8, 2023 Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S420... Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... Class II Medtronic Sofamor Danek USA Inc
Feb 8, 2023 Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3C... Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... Class II Medtronic Sofamor Danek USA Inc
Feb 8, 2023 Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) ... Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... Class II Medtronic Sofamor Danek USA Inc
Feb 8, 2023 Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; ... Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... Class II Medtronic Sofamor Danek USA Inc
Feb 8, 2023 Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STR... Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... Class II Medtronic Sofamor Danek USA Inc
Feb 8, 2023 Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; ... Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... Class II Medtronic Sofamor Danek USA Inc
Feb 8, 2023 Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, R... Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... Class II Medtronic Sofamor Danek USA Inc
Feb 8, 2023 Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM ... Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... Class II Medtronic Sofamor Danek USA Inc
Feb 8, 2023 Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF... Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... Class II Medtronic Sofamor Danek USA Inc
Feb 8, 2023 Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; ... Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... Class II Medtronic Sofamor Danek USA Inc
Feb 8, 2023 Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106;... Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... Class II Medtronic Sofamor Danek USA Inc
Feb 8, 2023 Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b)... Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch pack... Class II Medtronic Sofamor Danek USA Inc
Jan 20, 2023 SenSight Connector Plug, Model Number B31061. Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B... Class II Medtronic Neuromodulation
Dec 15, 2022 AxiEM" Non-Invasive Patient Tracker Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints an... Class II Medtronic Navigation, Inc.
Dec 12, 2022 DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10 DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic No... Class II DeRoyal Industries Inc
Dec 12, 2022 Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... Class II Medtronic Perfusion Systems
Dec 12, 2022 Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with... An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... Class II Medtronic Perfusion Systems

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.