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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
Nov 2, 2023 Sperm separation media are used to separate motile sperm from other constitue... The lower layer component of a sperm separation Kit does not match the certificate of analysis. T... Class II Fujifilm Irvine Scientific, Inc.
Jan 16, 2023 Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305 Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products. Class II Fujifilm Irvine Scientific, Inc.
Sep 8, 2021 Vit Kit-Freeze is intended for use in assisted reproductive procedures for vi... Due to a component in kit being labeled with the incorrect Expiration Date Class II Fujifilm Irvine Scientific, Inc.
Sep 8, 2021 Vit Kit-Freeze is intended for use in assisted reproductive procedures for vi... Due to a component in kit being labeled with the incorrect Expiration Date Class II Fujifilm Irvine Scientific, 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.