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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.