Browse Device Recalls
157 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 157 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 157 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 15, 2015 | GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda ... | The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit... | Class II | GE Medical Systems, LLC |
| Dec 7, 2015 | GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Us... | Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious ... | Class II | GE Medical Systems, LLC |
| Dec 7, 2015 | GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2. | GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex ... | Class II | GE Medical Systems, LLC |
| Nov 13, 2015 | GE Healthcare Optima CL323i Product Usage: The angiographic X-ray system... | GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable ... | Class II | GE Medical Systems, LLC |
| Nov 13, 2015 | GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray syste... | GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable ... | Class II | GE Medical Systems, LLC |
| Oct 23, 2015 | GE Healthcare, Revolution CT Scanners. Revolution CT- The system is inte... | GE Healthcare has recently become aware of a potential issue with routine head scans on your Revo... | Class II | GE Medical Systems, LLC |
| Sep 23, 2015 | MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UP... | GE became aware of an issue with the table transfer release mechanism of the MR Surgical Suite Op... | Class II | GE Medical 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.