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Browse Device Recalls

21 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 21 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 21 FDA device recalls.

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DateProductReasonClassFirm
Aug 26, 2025 GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH0500... Reports of vascular graft delamination, which may lead to reduced access flow; cannulation diffic... Class II W L Gore & Associates, Inc.
Jul 1, 2024 Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the followi... Due to packaging defects, sterility assurance and heparin activity may be compromised. Class II W L Gore & Associates, Inc.
Jul 1, 2024 Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the followi... Due to packaging defects, sterility assurance and heparin activity may be compromised. Class II W L Gore & Associates, Inc.
Dec 14, 2022 GORE CARDIOFORM Septal Occluder, REF: GSX0030A Septal Occluders released with incomplete quality test documentation that assesses the release of... Class II W L Gore & Associates, Inc.
Sep 21, 2022 GORE CARDIOFORM ASD Occluder. cardiovascular implant. Due to manufacturing records (Release Test Results) indicating "Failed". Class II W L Gore & Associates, Inc.
Sep 7, 2021 Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E... Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, howe... Class II W L Gore & Associates, Inc.
Sep 2, 2021 REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter... Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... Class II W L Gore & Associates, Inc.
Sep 2, 2021 REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter... Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... Class II W L Gore & Associates, Inc.
Sep 2, 2021 REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter... Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... Class II W L Gore & Associates, Inc.
Sep 2, 2021 REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diamete... Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... Class II W L Gore & Associates, Inc.
Sep 2, 2021 REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diamete... Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... Class II W L Gore & Associates, Inc.
Sep 2, 2021 REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter... Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... Class II W L Gore & Associates, Inc.
Sep 2, 2021 REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter... Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... Class II W L Gore & Associates, Inc.
Sep 2, 2021 REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter... Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... Class II W L Gore & Associates, Inc.
Sep 2, 2021 REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter... Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... Class II W L Gore & Associates, Inc.
May 12, 2021 Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, L... Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vasc... Class II W L Gore & Associates, Inc.
May 12, 2021 Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, L... Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vasc... Class II W L Gore & Associates, Inc.
Sep 9, 2020 GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System Due to secondary deployment fiber being attached to secondary deployment handle, completion of de... Class II W L Gore & Associates, Inc.
Sep 9, 2020 GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System When the delivery catheter was attempted to be removed, there was an observed connection between ... Class II W L Gore & Associates, Inc.
Dec 17, 2019 Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This d... The incorrect label was placed on both the primary and secondary package. Class II W L Gore & Associates, Inc.
Sep 25, 2017 GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic End... Incomplete and/or partial deployment of the CTAG Device during the endovascular procedure. Class II W L Gore & Associates, 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.