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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.

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DateProductReasonClassFirm
Mar 6, 2013 Alaris PC unit model 8015 with software version 9.12 Product Usage: The... The recall was initiated because Carefusion has identified potential risk associated with bolus p... Class II Carefusion Corporation
Mar 6, 2013 Alaris PC unit model 8015 with software version 9.12 Product Usage: The A... The recall was initiated because Carefusion has received reports of a communication error on the ... Class I Carefusion Corporation
Nov 20, 2009 Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 20... The recall was initiated because Carefusion has confirmed that when the PAS 2000 drawers due to i... Class II CareFusion Corporation

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.