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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
Jul 2, 2015 0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Ster... Procedures for the acceptance and control of in-process product have not been adequately establis... Class II MRP, LLC dba AMUSA
Apr 27, 2015 0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, ... Incorrect expiration date on label Class II MRP, LLC dba AMUSA
Feb 9, 2015 T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, ... Incorrect labeling of the expiration date Class II MRP, LLC dba AMUSA

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.