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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.

Clear
DateProductReasonClassFirm
Dec 3, 2025 Philips Incisive CT Potential for incomplete scan due to unstable connection inside of floating sensor. Class II Philips Healthcare (Suzhou) Co., Ltd.
Dec 23, 2022 Incisive CT, model 728143 & 728144 running Software Version 5.0.0. Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts ... Class II Philips Healthcare (Suzhou) Co., Ltd.
Feb 24, 2021 Philips CT systems are advanced continuous-rotation computed tomography syste... Philips has internally detected an issue with the actuators used in the Incisive CT couch, which ... Class II Philips Healthcare (Suzhou) Co., Ltd.

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.