W L Gore & Associates, Inc. recalls
Every recall we track for W L Gore & Associates, Inc. — 32 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from W L Gore & Associates, Inc. fell by more than half in 2025 (1, down from 4 in 2024).
All FDA recall records for W L Gore & Associates, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 1 | 0 | 0 | 1 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 2 | 0 | 2 |
| 2020 | 0 | 3 | 0 | 1 | 4 |
| 2021 | 0 | 1 | 13 | 0 | 14 |
| 2022 | 0 | 1 | 0 | 1 | 2 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 4 | 0 | 4 |
| 2025 | 0 | 0 | 1 | 0 | 1 |
| 2026 (to date) | 0 | 1 | 2 | 1 | 4 |
Most common reasons for W L Gore & Associates, Inc. recalls
What to do if you have a recalled W L Gore & Associates, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All W L Gore & Associates, Inc. recalls
20 shown- Lower riskMedical device
W L Gore & Associates, Inc. recalls Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product
W L Gore recalls 32 units of GORE VIABIL Short Wire Biliary Endoprosthesis (models VSWVH0808 and VSWVN1006) due to potential mislabeling with incorrect length.
W L GoreSep 3, 2026 - UnratedMedical device
W L Gore & Associates, Inc. recalls GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to
W L Gore recalls GORE VIABIL Short Wire Biliary Endoprosthesis Model VSWVN1006 due to incorrect labeling that could lead to improper medical use. Affected units have specific serial numbers and catalog codes.
W L GoreMay 22, 2026 - Use cautionMedical device
W L Gore & Associates, Inc. recalls GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes
W L Gore recalls specific Thoracic Branch Endoprosthesis Side Branch Components (TSB081006A, TSB081206A, etc.) due to catheter separation risk. Affected units include certain model numbers sold in US, Canada, EMEA, Australia, New Zealand, Japan, China, and Taiwan.
W L GoreMay 19, 2026 - Lower riskMedical device
W L Gore & Associates, Inc. recalls GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J,
W L Gore recalls ACUSEAL Vascular Graft models ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, and others due to reported delamination causing bleeding, bruising, and cannulation difficulties.
W L GoreAug 26, 2025 - Lower riskMedical device
W.L. Gore & Associates, Inc. recalls GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
W. L. Gore recalls GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement with incorrect expiration date label. Products labeled with four years instead of two years may be unsafe.
W. L. GoreJul 3, 2024 - Lower riskMedical device
W L Gore & Associates, Inc. recalls Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States:
W L Gore & Associates, Inc. is a leading manufacturer of high-performance materials and products. Explore our extensive product catalog for industrial, medical, and consumer applications.
W L Gore & Associates, Inc.Jul 1, 2024 - Lower riskMedical device
W.L. Gore & Associates, Inc. recalls GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with
W. L. Gore recalls specific models of short wire biliary endoprosthesis with potential labeling errors that could lead to extended procedure times, unplanned removal, or infections. Affected units include catalog numbers VSWVH1008 and VSWVN1008 with specific serial numbers.
W. L. GoreJan 19, 2024 - Use cautionMedical device
W L Gore & Associates, Inc. recalls GORE CARDIOFORM Septal Occluder, REF: GSX0030A
W L Gore recalls GORE CARDIOFORM Septal Occluder models with incomplete quality test documentation that could lead to embolization or serious injury during cardiac procedures.
W L GoreDec 14, 2022 - UnratedMedical device
W L Gore & Associates, Inc. recalls GORE CARDIOFORM ASD Occluder. cardiovascular implant.
W L Gore recalls specific GORE CARDIOFORM ASD Occluder implants due to failed manufacturing tests. Affected units have unique model and serial numbers. Consumers should contact the company for details.
W L GoreSep 21, 2022 - Lower riskMedical device
W L Gore & Associates, Inc. recalls Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON
W L Gore recalls specific heparin stents due to incorrect labeling that may contain a larger size than listed. Affected units have serial numbers starting with 22753580.
W L GoreSep 7, 2021 - Lower riskMedical device
W L Gore & Associates, Inc. recalls REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery
W L Gore recalls Cardioform Septal Occluder 30mm with 3-year expiration label instead of 2-year. Product sold outside US with specific serial numbers.
W L GoreSep 2, 2021 - Use cautionMedical device
W. L. Gore & Associates Inc. recalls Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire
W. L. Gore recalls specific balloon catheters for potential leakage during use, which could cause insufficient inflation or inability to inflate. Affected units have serial numbers between 22982051 and 23516741.
W. L. GoreJul 12, 2021 - Lower riskMedical device
W L Gore & Associates, Inc. recalls Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the
Gore recalls pediatric vascular grafts that may be incorrectly labeled as 5mm or 6mm. This could lead to improper medical use if the wrong size is used during surgery.
GoreMay 12, 2021 - Lower riskMedical device
W.L. Gore & Associates, Inc. recalls GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040,
Gore recalls biliary endoprosthesis stents and drains that may be shorter than labeled, potentially causing improper placement in bile ducts. Affected units include specific catalog and serial numbers.
GoreApr 5, 2021 - UnratedMedical device
W L Gore & Associates, Inc. recalls GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
W L Gore recalls thoracic stent grafts with ACTIVE CONTROL System due to deployment failure risk. Affected models include TGM212110X* through TGMR404020X* with specific catalog numbers.
W L GoreSep 9, 2020 - Use cautionMedical device
W L Gore & Associates, Inc. recalls GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
W L Gore recalls conformable thoracic stent grafts with Active Control System due to delivery catheter connection preventing removal. Affected units include specific catalog numbers and all lot numbers. Consumers should contact for details.
W L GoreSep 9, 2020 - Use cautionMedical device
W. L. Gore & Associates Inc. recalls GORE¿ EXCLUDER¿ AAA Endoprosthesis
Gore recalls certain AAA endoprosthesis models due to reports of leading end catheter component separations. Affected products include specific catalog numbers and sizes. Consumers should contact Gore for details.
GoreJan 6, 2020 - Lower riskMedical device
W L Gore & Associates, Inc. recalls Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair
W L Gore recalls specific Conformable Thoracic Stent Graft models with incorrect labeling that could lead to improper use. Affected units have serial numbers 21225065-21225084.
W L GoreDec 17, 2019 - Lower riskMedical device
W. L. Gore & Associates Inc. recalls Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L.
W. L. Gore recalls sterile 14Fr DrySeal Flex Introducer Sheaths mislabeled as 14Fr when they are 16Fr. Check serial numbers for affected units.
W. L. GoreNov 18, 2019 - Use cautionMedical device
W L Gore & Associates, Inc. recalls GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular
W L Gore recalls GORE TAG Thoracic Endoprosthesis with serial numbers starting TGE212110. Incomplete deployment during surgery may cause complications. Affected patients should contact the manufacturer for details.
W L GoreSep 25, 2017
W L Gore & Associates, Inc. recall questions
How many recalls has W L Gore & Associates, Inc. had?
32 recalls from W L Gore & Associates, Inc. are on record with U.S. safety agencies, from 2017–2026.
What is the most recent W L Gore & Associates, Inc. recall?
W L Gore & Associates, Inc. recalls Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product, dated Sep 3, 2026. Every W L Gore & Associates, Inc. recall is listed on this page, newest first.
Why are W L Gore & Associates, Inc. products recalled?
The most common reasons on record: Firm has received reports of leading end catheter component separations. (2).
What should I do if I have a recalled W L Gore & Associates, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new W L Gore & Associates, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.