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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 1, 2024 McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for ... Due to defects on primary packaging pouch that compromise the device's ability to maintain a ster... Class II Advanced Medical Solutions Ltd.
Oct 1, 2024 Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate... Due to defects on primary packaging pouch that compromise the device's ability to maintain a ster... Class II Advanced Medical Solutions Ltd.
Oct 1, 2024 MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLIN... Due to defects on primary packaging pouch that compromise the device's ability to maintain a ster... Class II Advanced Medical Solutions Ltd.
Jan 15, 2015 ReliaMed¿ Alginate/CMC. Each dressing is packed in a pouch (primary packagin... On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering... Class II Advanced Medical Solutions Ltd.
Jan 15, 2015 ReliaMed¿ Silver Alginate/CMC. Each dressing is packed in a pouch (primary pa... On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discoverin... Class II Advanced Medical Solutions 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.