Browse Device Recalls
9 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 9 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 9 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 10, 2016 | FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow¿ I... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is util... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow¿ IAB is uti... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aort... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is uti... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilize... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow¿ IAB is utilize... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilize... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
| Feb 10, 2016 | Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is uti... | The sheath body may become separated from the sheath hub. If the separation occurs, there is a po... | Class I | Arrow International, Inc., Division of Teleflex... |
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.