Browse Device Recalls
8 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 8 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 8 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 19, 2016 | Apollo EZ: Model: 9784152036 Multi-function x-ray systems capable of routi... | The analysis showed that the incident was caused by a chain of four faults: 1.) The injured pers... | Class II | Villa Radiology Systems LLC |
| Feb 19, 2016 | Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of rout... | The analysis showed that the incident was caused by a chain of four faults: 1.) The injured pers... | Class II | Villa Radiology Systems LLC |
| Feb 19, 2016 | Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine ra... | The analysis showed that the incident was caused by a chain of four faults: 1.) The injured pers... | Class II | Villa Radiology Systems LLC |
| Feb 19, 2016 | Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9... | The analysis showed that the incident was caused by a chain of four faults: 1.) The injured pers... | Class II | Villa Radiology Systems LLC |
| Aug 5, 2015 | Villa Sistemi Rotograph EVO 3D X-ray | It has been discovered that due to lack of information accompanying documents the product fails t... | Class II | Villa Radiology Systems LLC |
| Aug 5, 2015 | Owandy Radiology I -MAX Touch 3D X-ray | It has been discovered that due to lack of information accompanying documents the product fails t... | Class II | Villa Radiology Systems LLC |
| Dec 14, 2014 | Juno DFR X-ray system | The system does not provide the appropriate audible signal, permanent activation, and manual over... | Class II | Villa Radiology Systems LLC |
| Aug 2, 2013 | Juno DRF System. Mobile X-ray system These are general, multi-function x-r... | It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro m... | Class II | Villa Radiology Systems LLC |
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.