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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 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 11 FDA device recalls.

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DateProductReasonClassFirm
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101863MD ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101863DO ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101663DO ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. 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.