Browse Device Recalls

1,730 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,730 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 1,730 FDA device recalls.

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DateProductReasonClassFirm
Jul 14, 2014 Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, S... Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potent... Class II Medtronic Neuromodulation
Jul 11, 2014 Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intr... Medtronic is removing specific lots of the Ascenda Intrathecal Catheters and Revision Kits, which... Class II Medtronic Neuromodulation
Jun 16, 2014 Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D Medtronic MiniMed is recalling the Implantable Insulin Pump because there have been reports of a ... Class II Medtronic MiniMed Inc.
Jun 11, 2014 Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. F... Potential for misalignment of the Z-stage scale. Using one of these devices for a procedure could... Class II Medtronic Neuromodulation
Jun 9, 2014 Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems b... Class I Medtronic Neurosurgery
Jun 9, 2014 Medtronic Duet External Drainage and Monitoring System, SmartSite Injection S... Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems b... Class I Medtronic Neurosurgery
Jun 9, 2014 Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems b... Class I Medtronic Neurosurgery
Jun 9, 2014 Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems b... Class I Medtronic Neurosurgery
Jun 9, 2014 Medtronic Duet External Drainage and Monitoring System, SmartSite Injection S... Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems b... Class I Medtronic Neurosurgery
May 2, 2014 Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtron... Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP lim... Class II Medtronic Neuromodulation
Apr 29, 2014 Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Gene... Events related to a pacing rate outside of the intended setting, including events of sudden incre... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Apr 24, 2014 DISP 9730951 STRL SPHERE, 5PK INSERT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 PACK 9731975 TUMOR RESECTION AXIEM CR Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 BAG 9732315 MOUSE STERILE 15 PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 PIN, 9733235, 100MM, STERILE, PERC REF Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 PATIENT TRACKER 9733534XOM ENT 1PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 BIOPSY NEEDLE KIT, 9733068, PASSIVE Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 INST 9731132 KIT CR REF FRAME DRIVER 5PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 TUMOR RESECTION KIT 9733608 SKULL MOUNT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 PIN, 9733236, 150MM, STERILE, PERC REF Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 TRAJ GUIDE KIT, 9733066, BIOPSY, INT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 DISP 9730950 STRL SPHERE, 1 PK INSERT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 INSTRUMENT TRACKER 9733533XOM ENT 1PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 SHUNT KIT 9733605 NON-INVASIVE Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 TUMOR RESECTION KIT 9733607 NON-INVASIVE Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 SPHERES 8801075 5/TRAY 12PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 BIT 9733516 2.9mm DRILL STERILE Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 TRAJ GUIDE KIT, 9733065, BIOPSY, EXT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 SPHERES 8801071 1/TRAY 12PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 MOUSE 9732721 STERILE O-ARM 10PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 ENT PRGM 9734636 ADD FUSION NAV AxiEM Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 KIT, 9731427, THORACIC TACTILE PROBES Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 TUMOR RES. PACK 9733553 AxiEM S.M. Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 DRAPE 9732722 TUBE STERILE O-ARM 20PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 UPGRD PRGM 9734638 ADD AxiEM NAVIGATION Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 4, 2014 Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtr... Some refill kits in the affected lots may contain an extension tubing set that is occluded and he... Class II Medtronic Neuromodulation
Mar 13, 2014 Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-5... Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have re... Class II Medtronic MiniMed Inc.
Mar 3, 2014 FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm... Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System... Class II Medtronic Vascular, Inc.
Mar 3, 2014 FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm,... Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System... Class II Medtronic Vascular, Inc.
Mar 3, 2014 FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm,... Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System... Class II Medtronic Vascular, Inc.
Feb 27, 2014 Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including t... Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea... Class II Medtronic Neuromodulation
Feb 27, 2014 Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), Restore... Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea... Class II Medtronic Neuromodulation
Feb 27, 2014 Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC... Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea... Class II Medtronic Neuromodulation
Feb 26, 2014 Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-... This recall provides important new information regarding overinfusion associated with the Medtron... Class II Medtronic Neuromodulation
Feb 6, 2014 Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2... Incorrect master label. Class III Medtronic Vascular
Jan 30, 2014 Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 7882... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-V... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP ... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-V... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management

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.