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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 17, 2025 Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed pos... Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positiv... Class II TECHNO-PATH MANUFACTURING LTD.
Oct 17, 2025 Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassa... Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positiv... Class II TECHNO-PATH MANUFACTURING LTD.
Aug 25, 2023 Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19 Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill ... Class II TECHNO-PATH MANUFACTURING LTD.
Aug 25, 2023 Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12 Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill ... Class II TECHNO-PATH MANUFACTURING LTD.
Aug 25, 2023 Multichem P, Part Code 08P90-10 Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill ... Class II TECHNO-PATH MANUFACTURING LTD.

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.