W L Gore & Associates, Inc.
Complete recall history across all FDA and CPSC categories — 21 total recalls
W L Gore & Associates, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (21)
FDA medical device enforcement actions by W L Gore & Associates, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Aug 26, 2025 | GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH0500... | Reports of vascular graft delamination, which may lead to reduced access flow... | Class II |
| Jul 1, 2024 | Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the followi... | Due to packaging defects, sterility assurance and heparin activity may be com... | Class II |
| Jul 1, 2024 | Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the followi... | Due to packaging defects, sterility assurance and heparin activity may be com... | Class II |
| Dec 14, 2022 | GORE CARDIOFORM Septal Occluder, REF: GSX0030A | Septal Occluders released with incomplete quality test documentation that ass... | Class II |
| Sep 21, 2022 | GORE CARDIOFORM ASD Occluder. cardiovascular implant. | Due to manufacturing records (Release Test Results) indicating "Failed". | Class II |
| Sep 7, 2021 | Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E... | Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x... | Class II |
| Sep 2, 2021 | REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter... | Septal Occluders contain the incorrect expiration date. Product is labeled wi... | Class II |
| Sep 2, 2021 | REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter... | Septal Occluders contain the incorrect expiration date. Product is labeled wi... | Class II |
| Sep 2, 2021 | REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter... | Septal Occluders contain the incorrect expiration date. Product is labeled wi... | Class II |
| Sep 2, 2021 | REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diamete... | Septal Occluders contain the incorrect expiration date. Product is labeled wi... | Class II |
| Sep 2, 2021 | REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diamete... | Septal Occluders contain the incorrect expiration date. Product is labeled wi... | Class II |
| Sep 2, 2021 | REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter... | Septal Occluders contain the incorrect expiration date. Product is labeled wi... | Class II |
| Sep 2, 2021 | REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter... | Septal Occluders contain the incorrect expiration date. Product is labeled wi... | Class II |
| Sep 2, 2021 | REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter... | Septal Occluders contain the incorrect expiration date. Product is labeled wi... | Class II |
| Sep 2, 2021 | REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter... | Septal Occluders contain the incorrect expiration date. Product is labeled wi... | Class II |
| 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 labe... | Class II |
| 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 labe... | Class II |
| Sep 9, 2020 | GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System | Due to secondary deployment fiber being attached to secondary deployment hand... | Class II |
| 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... | Class II |
| 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 |
| Sep 25, 2017 | GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic End... | Incomplete and/or partial deployment of the CTAG Device during the endovascul... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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