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Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 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 10 FDA device recalls.

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DateProductReasonClassFirm
Dec 13, 2024 Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Mod... Potential for hole in package compromising sterility of the medical kit. Class II Trinity Sterile, Inc.
Dec 13, 2024 Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dres... Potential for hole in package compromising sterility of the medical kit. Class II Trinity Sterile, Inc.
Dec 13, 2024 Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Teg... Potential for hole in package compromising sterility of the medical kit. Class II Trinity Sterile, Inc.
Dec 13, 2024 Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep ... Potential for hole in package compromising sterility of the medical kit. Class II Trinity Sterile, Inc.
Dec 13, 2024 Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa... Potential for hole in package compromising sterility of the medical kit. Class II Trinity Sterile, Inc.
Jun 29, 2022 Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains... Class II Trinity Sterile, Inc.
Jun 29, 2022 Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains... Class II Trinity Sterile, Inc.
Jun 29, 2022 Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5... Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains... Class II Trinity Sterile, Inc.
Jun 29, 2022 Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708 Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains... Class II Trinity Sterile, Inc.
Feb 23, 2021 Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended ... Evidence of face masks or other material in the seal in several kits, causing improper seals and ... Class II Trinity Sterile, 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.