--- title: "W L Gore & Associates, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search W L Gore & Associates, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/w-l-gore-associates-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # W L Gore & Associates, Inc. recall records **10** reported ongoing 10 records in this archive. Latest source date May 22, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status May 22, 2026 FDA device enforcement ### [GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which ma...](https://isitonrecall.com/recall/fda-device-z-2914-2026-gore-viabil-short-wire-biliary-endoprosthesis-model-no-vswvn1010-flexible-self-expanding-endoprosthe/) 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010). Class II Reported ongoing Distribution: U.S. Nationwide distribution in the states of GA and RI. [Official source for GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endo...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2914-2026%22) May 22, 2026 FDA device enforcement ### [GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which ma...](https://isitonrecall.com/recall/fda-device-z-2915-2026-gore-viabil-short-wire-biliary-endoprosthesis-model-no-vswvn1006-flexible-self-expanding-endoprosthe/) 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010). Class II Reported ongoing Distribution: U.S. Nationwide distribution in the states of GA and RI. [Official source for GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endo...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2915-2026%22) May 19, 2026 FDA device enforcement ### [GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, ...](https://isitonrecall.com/recall/fda-device-z-2672-2026-gore-tag-thoracic-branch-endoprosthesis-side-branch-component-catalog-numbers-by-region-united-state/) Due to catheter separation Class II Reported ongoing Distribution: Worldwide - U.S. Nationwide distribution including in the states and territories of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, N... [Official source for GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) Unite...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2672-2026%22) Aug 26, 2025 FDA device enforcement ### [GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ...](https://isitonrecall.com/recall/fda-device-z-0036-2026-gore-acuseal-vascular-graft-ref-ech050020j-ech050020w-ech050050j-ech050050w-ech060010a-ech060020a-ec/) Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to modify existing warning to 1) further c... Class II Reported ongoing Distribution: US: OR, AL, OH, MD, VA, CA, FL, NC, OK, MA, MO, AZ, TX, IL, GA, PA, NH, HI, MN, MS, KY, ID, LA, NJ, TN, DE, IN, MI, WI, NY, DC, SC, CT, NE, IA, WA, AR, NV, WV, AK, UT, ND, KS, C... [Official source for GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0036-2026%22) Jul 3, 2024 FDA device enforcement ### [GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;](https://isitonrecall.com/recall/fda-device-z-2513-2024-gore-seamguard-bioabsorbable-staple-line-reinforcement-configured-for-circular-staplers-25mm-catalog/) Devices were labeled with an expiration date of four years and ten days rather than the validated two years. Class II Reported ongoing Distribution: US Nationwide distribution in the states of CA, GA, IL, NC, OH, OK, WA. [Official source for GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Ca...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2513-2024%22) Jul 1, 2024 FDA device enforcement ### [Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB05290...](https://isitonrecall.com/recall/fda-device-z-2945-2024-heparin-gore-viabahn-vbx-balloon-expandable-endoprosthesis-for-the-following-reference-numbers-unite/) Due to packaging defects, sterility assurance and heparin activity may be compromised. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC,... [Official source for Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2945-2024%22) Jul 1, 2024 FDA device enforcement ### [Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB055902C, BXB063902C, BXB065902C, BXB067902C, BXB073902C, BXB...](https://isitonrecall.com/recall/fda-device-z-2946-2024-heparin-gore-viabahn-vbx-balloon-expandable-endoprosthesis-for-the-following-reference-numbers-unite/) Due to packaging defects, sterility assurance and heparin activity may be compromised. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC,... [Official source for Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2946-2024%22) Jan 19, 2024 FDA device enforcement ### [GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number VSWVN1008, 10 mm x 8 cm; no holes](https://isitonrecall.com/recall/fda-device-z-1179-2024-gore-viabil-short-wire-biliary-endoprosthesis-product-labeled-as-1-catalog-number-vswvh1008-10-mm-x/) Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, unplanned device removal, secondary procedure, cholangitis, cholecystitis, and/o... Class II Reported ongoing Distribution: US Nationwide distribution in the state of Georgia. [Official source for GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 1...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1179-2024%22) Dec 14, 2022 FDA device enforcement ### [GORE CARDIOFORM Septal Occluder, REF: GSX0030A](https://isitonrecall.com/recall/fda-device-z-1048-2023-gore-cardioform-septal-occluder-ref-gsx0030a/) Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could potentially result could result in occluder embo... Class II Reported ongoing Distribution: US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA, MO, SD, VA. [Official source for GORE CARDIOFORM Septal Occluder, REF: GSX0030A](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1048-2023%22) Sep 21, 2022 FDA device enforcement ### [GORE CARDIOFORM ASD Occluder. cardiovascular implant.](https://isitonrecall.com/recall/fda-device-z-0136-2023-gore-cardioform-asd-occluder-cardiovascular-implant/) Due to manufacturing records (Release Test Results) indicating "Failed". Class II Reported ongoing Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GA, IA, ID, IL, ME, MN, NC, NY, JPA, TN, TX, WA, and WI. The countries of De... [Official source for GORE CARDIOFORM ASD Occluder. cardiovascular implant.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0136-2023%22) ## Reasons in these listed records - 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010). - Due to catheter separation - Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to modify existing warning to 1) further clarify techniques th... - Devices were labeled with an expiration date of four years and ten days rather than the validated two years. These examples come from this result page and are not a ranking of every recall reason. ## Checking W L Gore & Associates, Inc. ### Is there a recall on w l gore & associates, inc. right now? This archive contains 10 records, including 10 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search W L Gore & Associates, Inc.](https://isitonrecall.com/check/?q=W%20L%20Gore%20%26%20Associates%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)