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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Oct 18, 2024 Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions re... Class II LivaNova Deutschland GmbH
Aug 3, 2023 3T Heater Cooler System, REF: 16-02-85 The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance sch... Class II LivaNova Deutschland GmbH
Dec 17, 2021 Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI... One ferrite ring expected to be installed on centrifugal pump system power cable may not be present. Class III LivaNova Deutschland GmbH
Aug 26, 2019 Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-... The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used... Class II LivaNova Deutschland GmbH
Aug 26, 2019 Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15,... The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used... Class II LivaNova Deutschland GmbH

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.