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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Apr 2, 2024 Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S) A packaging seal gap could impact the sterility of the product. Class II Andover Healthcare Inc.
Jun 19, 2019 Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing o... Incomplete packaging seal of sterile product Class II Andover Healthcare Inc.
Jun 19, 2019 Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing o... Incomplete packaging seal of sterile product Class II Andover Healthcare Inc.
Jun 19, 2019 Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or... Incomplete packaging seal of sterile product Class II Andover Healthcare Inc.
Jun 19, 2019 Sterile Co-Flex Med 3" - Product Usage: Single Use secondary wound dressing o... Incomplete packaging seal of sterile product Class II Andover Healthcare Inc.
Jun 19, 2019 Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing o... Incomplete packaging seal of sterile product Class II Andover Healthcare Inc.
Jun 19, 2019 Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or... Incomplete packaging seal of sterile product Class II Andover Healthcare 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.