Browse Device Recalls
2 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2 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 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 11, 2018 | GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 Th... | CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (... | Class II | GE Medical Systems Information Technologies, Inc. |
| Jul 13, 2017 | CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitor... | Device does not produce a visual or audible impedance respiration APN alarm when an impedance res... | Class II | GE Medical Systems Information Technologies, Inc. |
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.