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Browse Device Recalls

150 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 150 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 150 FDA device recalls.

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DateProductReasonClassFirm
Sep 9, 2024 iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616 There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label. Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 7X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 8X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 5-8X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 7X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 8X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 7X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 6X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 6X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 6X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 FLIXENE, 6X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 FLIXENE, 4-7X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 4-6X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 5X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 6X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 8X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 FLIXENE, 7X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 6X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 6X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 6X45, 1GDS, CH, STR-SW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 7X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 6X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 8X40, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 FLIXENE, 6X30, 1GDS, STR. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 6X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 8X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 6X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 8X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 8X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 5-8X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 4-7X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 6X100, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 FLIXENE, 6X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 4-7X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 6X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 7X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 8X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 FLIXENE, 6X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 4-7X70, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 4-7X45, 2GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 6X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 8X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 FLIXENE, 4-7X30, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 8X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 7X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 5X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 5X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation
May 3, 2024 ADVANTA VXT, 4-6X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a nota... Class II Atrium Medical Corporation

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.