Browse Device Recalls
3 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3 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 3 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 14, 2018 | ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Eur... | A component of the device was recalled by a supplier. In rare cases of inadequate maintenance or ... | Class II | Swissray Medical AG |
| Nov 18, 2016 | ddR Formula B X-ray System, Model ddR Formula B X-ray system used for ima... | Potential for bucky (the part that holds the grid and is moveable to position the patient) moving... | Class II | Swissray Medical |
| Aug 9, 2016 | ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system u... | Possible injury due to movement of the arm, calibration loss and communication loss. | Class II | Swissray Medical |
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.