Browse Device Recalls
10 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 10 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 10 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 11, 2026 | Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, ... | ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 cath... | Class II | Medtronic, Inc. |
| Oct 29, 2025 | Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable ... | There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of even... | Class II | Medtronic, Inc. |
| Jun 18, 2025 | Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the fol... | In prior SmartSync application versions, the Abort button stopped the test that was selected. Dur... | Class II | Medtronic, Inc. |
| Jun 18, 2025 | Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the f... | In prior SmartSync application versions, the Abort button stopped the test that was selected. Dur... | Class II | Medtronic, Inc. |
| Jun 17, 2025 | Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Mod... | A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. ... | Class II | Medtronic, Inc. |
| Jun 17, 2025 | Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Num... | A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. ... | Class II | Medtronic, Inc. |
| Apr 29, 2025 | Azure S DR MRI SureScan, Product number W3DR01 | Identified devices may experience sudden battery power failure without alarm, power supply power-... | Class II | Medtronic, Inc. |
| Jan 9, 2014 | Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obtura... | Medtronic, Inc. initiated a recall of Medtronic Mosaic Aortic Obturator Model 7305 used with th... | Class II | Medtronic Cardiovascular Surgery-the Heart Valv... |
| Sep 16, 2013 | NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; M... | Compliance chart included in lot 207002011 of the NC Sprinter RX 2.25 x 12 mm products lists the ... | Class II | Medtronic Vascular, Inc. |
| Dec 3, 2012 | Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 3708... | Medtronic has identified 140 Restore DBS Extension Kits (model numbers 7482, 37085, and 37086), w... | Class II | Medtronic Neuromodulation |
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.