Browse Device Recalls
2,907 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,907 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 2,907 FDA device recalls in 2015.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 5, 2015 | Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment | Terumo Cardiovascular Systems (Terumo CVS) is voluntarily recalling certain lots of Titan" Stabi... | Class II | Terumo Cardiovascular Systems Corporation |
| Jan 5, 2015 | The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended f... | Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) L... | Class II | Clinical Innovations, LLC |
| Jan 5, 2015 | ARROW Epidural Needle Component (product number AN-05501). Epidural needles ... | The product labeling does not specify the 5 year shelf life of the product. | Class II | Arrow International Inc |
| Jan 2, 2015 | ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lume... | Foreign material found within the kits. The foreign material, white or black particles and/or thr... | Class II | Arrow International Inc |
| Jan 2, 2015 | EPWorks software used in the Xltek Protektor Stimulator Product Usage: In... | Software error occurs when using remote monitoring; if the remote user tries to stop the free run... | Class II | Natus Medical Incorporated |
| Jan 2, 2015 | Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR a... | Combination of CTVision with syngo RT Therapist / syngo RT Oncologist 4.3.SP1 automatic registrat... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 2, 2015 | EPWorks software used in the Protektor 32 Product Usage: Uses electroence... | Software error occurs when using remote monitoring; if the remote user tries to stop the free run... | Class II | Natus Medical Incorporated |
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.