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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
Jun 10, 2014 EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-... If the universal ingredient (UI) in an active configuration is changed using the Configuration Ed... Class II Baxter Healthcare Corp.
Aug 22, 2013 Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Si... Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer... Class II Baxa Corporation
Jun 4, 2013 ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system t... Baxter Healthcare is recalling certain ExactaMix automated compounding devices due to the complem... Class II Baxa Corporation
Oct 3, 2012 Repeater Pump, Class II device used for facilitating repeatable drug dosage d... The firm is issuing a field correction to the operators manual included with the 099 Repeater Pum... Class II Baxa 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.