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Browse Device Recalls

109 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 109 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 109 FDA device recalls.

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DateProductReasonClassFirm
Oct 20, 2015 12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP These Drugs of... Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class II Ameditech Inc
Oct 20, 2015 11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300)... Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class II Ameditech Inc
Oct 20, 2015 THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU, MTPA-8MBAU These Drugs ... Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class II Ameditech Inc
Oct 20, 2015 DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP),... Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class II Ameditech Inc
Oct 20, 2015 CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. ... Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class II Ameditech Inc
Oct 20, 2015 10-Panel Pipette Drug Screen, Item No. PSP-10M These Drugs of Abuse Tests ar... Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class II Ameditech Inc
Sep 23, 2014 ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs ... Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpreta... Class II Ameditech Inc
Sep 23, 2014 ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint L... Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpreta... Class II Ameditech Inc
Sep 23, 2014 ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. The ArcPoint La... Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpreta... Class II Ameditech Inc

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.