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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
Nov 15, 2019 AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of ca... The AIA-2000 bar code scanners depend on the quiet zone to help identify the bar code. The lack o... Class III Tosoh Smd Inc
Dec 22, 2016 Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reportin... Power outages causes reporting software to shutdown. Class II Tosoh Smd Inc
May 15, 2013 AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-6... Visual inspection of the pipette tips indicated that some of the tips were not uniform in size/le... Class II Tosoh Smd 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.