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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 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 11 FDA device recalls.

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DateProductReasonClassFirm
Apr 15, 2021 Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit... Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the t... Class II Vygon U.S.A.
Dec 6, 2018 Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002-... DualStop Caps defect causing leaks in affected product Class II Vygon U.S.A.
Dec 6, 2018 Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - ... DualStop Caps defect causing leaks in affected product Class II Vygon U.S.A.
Feb 28, 2018 PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PI... Potential friction holes may affect the sterility of the product. Class II Vygon U.S.A.
Feb 28, 2018 Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the ins... Potential friction holes may affect the sterility of the product. Class II Vygon U.S.A.
Feb 28, 2018 PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the in... Potential friction holes may affect the sterility of the product. Class II Vygon U.S.A.
Feb 28, 2018 Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insert... Potential friction holes may affect the sterility of the product. Class II Vygon U.S.A.
Feb 28, 2018 Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the ins... Potential friction holes may affect the sterility of the product. Class II Vygon U.S.A.
Feb 28, 2018 Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit f... Potential friction holes may affect the sterility of the product. Class II Vygon U.S.A.
Feb 28, 2018 PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the in... Potential friction holes may affect the sterility of the product. Class II Vygon U.S.A.
Feb 28, 2018 PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of ... Potential friction holes may affect the sterility of the product. Class II Vygon U.S.A.

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.