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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 29, 2025 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed. Class II Copan Italia
Oct 29, 2025 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum tr... Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed. Class II Copan Italia
May 2, 2025 BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro D... Swabs for specimen collection may be prone to breakage during product usage. Class II Copan Italia
Jul 9, 2021 COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the ... A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integr... Class II Copan Italia
Aug 9, 2013 WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrumen... The recall of the WASP (Walk Away Specimen Process) instrument was initiated because Copan Italia... Class III Copan Italia

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.