The Recall Desk

Manufacturer

W.L. Gore & Associates, Inc.

31 recalls in our database name W.L. Gore & Associates, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
31
Critical
0
Severe
3
Most recent
2026-08-19

Of the 31 recalls from W.L. Gore & Associates, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (10%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 31

  • ModerateFDA (Devices)·Z-2914-2026·2026-08-19

    GORE VIABIL Biliary Endoprosthesis Recalled for Incorrect Labeling

    W L Gore & Associates is recalling 13 GORE VIABIL Short Wire Biliary Endoprostheses because they were incorrectly labeled with the wrong model number and dimensions.

    Product
    GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2915-2026·2026-08-19

    GORE VIABIL Biliary Endoprosthesis Recalled for Incorrect Labeling

    W L Gore & Associates is recalling 13 GORE VIABIL Short Wire Biliary Endoprostheses because they were incorrectly labeled with the wrong model number and dimensions.

    Product
    GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2672-2026·2026-07-08

    GORE TAG Thoracic Branch Endoprosthesis Side Branch Component Recall

    W. L. Gore & Associates is recalling 467 GORE TAG Thoracic Branch Endoprosthesis Side Branch Components worldwide due to risk of catheter separation during deployment.

    Product
    GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB081706A, TSB121506A, TSB121706A, TSB122006A EMEA Countries, Australia, New Zealand:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0036-2026·2025-10-08

    Vascular grafts recalled after delamination reports prompt instructions for use update

    W. L. Gore is recalling 52,306 GORE ACUSEAL Vascular Grafts following reports of graft delamination, and is updating the instructions for use with expanded warnings.

    Product
    GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-2945-2024·2024-09-11

    Heparin Gore Viabahn VBX Endoprosthesis Recalled for Packaging Defects

    W L Gore & Associates is recalling Heparin Gore Viabahn VBX Balloon Expandable Endoprosthesis devices due to packaging defects that may compromise sterility assurance and heparin activity.

    Product
    Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901A BXB051902A BXB052901A BXB052902A BXB053901A BXB053902A BXB055901A BXB055902A BXB057901A BXB057902A BXB061501A BXB061502A BXB061
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2946-2024·2024-09-11

    W L Gore Recalls Heparin Viabahn VBX Endoprosthesis Due to Packaging Defects

    W L Gore & Associates is recalling specific lots of Heparin, Gore Viabahn VBX Balloon Expandable Endoprosthesis because packaging defects may compromise sterility and heparin activity.

    Product
    Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB055902C, BXB063902C, BXB065902C, BXB067902C, BXB073902C, BXB075902C, BXB077902C, BXB083902C, BXB085902C, BXB087902C, BXB093902C, BXB095902C, BXB097902C *Fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2513-2024·2024-08-14

    Surgical Staple Reinforcement Devices Recalled for Incorrect Expiration Dating

    W.L. Gore & Associates recalled 51 units of GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement due to incorrect expiration date labeling. The devices were labeled with a four-year and ten-day expiration date instead of the validated two-year shelf life.

    Product
    GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1179-2024·2024-02-28

    Biliary Endoprosthesis Labeling Mismatch Risks Incorrect Device Placement

    W.L. Gore's GORE VIABIL Short Wire Biliary Endoprosthesis may be mislabeled regarding drainage holes, risking extended procedures, infections, and unplanned device removal in 24 units distributed in Georgia.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1048-2023·2023-02-08

    GORE CARDIOFORM Septal Occluder Recalled for Incomplete Quality Documentation

    W L Gore & Associates is recalling 14 units of the GORE CARDIOFORM Septal Occluder (GSX0030A) due to incomplete quality test documentation. The missing verification of device release could pose a potential risk of device failure and serious complications.

    Product
    GORE CARDIOFORM Septal Occluder, REF: GSX0030A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0164-2022·2021-11-03

    Gore CARDIOFORM Septal Occluder recalled for incorrect expiration date

    W.L. Gore & Associates is recalling 2,238 GORE CARDIOFORM SEPTAL OCCLUDER 30 mm devices labeled with a 3-year expiration date instead of the actual 2-year expiration date.

    Product
    REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0170-2022·2021-11-03

    GORE CARDIOFORM Septal Occluder Recalled for Incorrect Expiration Date Labeling

    W L Gore & Associates is recalling 187 units of GORE CARDIOFORM Septal Occluders because they are labeled with a 3-year expiration date instead of the correct 2-year expiration date. Using the device beyond its actual shelf life could compromise its safety and effectiveness.

    Product
    REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620111 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0169-2022·2021-11-03

    GORE CARDIOFORM Septal Occluder devices labeled with incorrect expiration date

    W L Gore recalled 846 GORE CARDIOFORM Septal Occluder units labeled with a 3-year expiration instead of the correct 2-year expiration.

    Product
    REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617661 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0165-2022·2021-11-03

    GORE Cardioform Septal Occluder recalled for incorrect expiration date labeling

    W.L. Gore is recalling 138 units of GORE Cardioform Septal Occluder devices labeled with a 3-year expiration date instead of the actual 2-year shelf life.

    Product
    REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631018
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0171-2022·2021-11-03

    Septal Occluder Devices Recalled for Incorrect Expiration Date Label

    W L Gore & Associates is recalling 222 GORE Cardioform Septal Occluder devices labeled with a 3-year expiration date instead of the correct 2-year expiration.

    Product
    REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • ModerateFDA (Devices)·Z-0168-2022·2021-11-03

    GORE CARDIOFORM Septal Occluder Labeled with Incorrect Expiration Date

    W L Gore & Associates is recalling GORE CARDIOFORM Septal Occluder devices labeled with a 3-year expiration date instead of the correct 2-year date. Mislabeling could result in use of devices beyond their intended safe lifespan.

    Product
    REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617647 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • ModerateFDA (Devices)·Z-0166-2022·2021-11-03

    GORE CARDIOFORM Septal Occluders Recalled for Incorrect Expiration Date

    W. L. Gore & Associates is recalling GORE CARDIOFORM Septal Occluders labeled with incorrect 3-year expiration dates instead of 2-year dates. This labeling error affects devices distributed across the United States and internationally.

    Product
    REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • ModerateFDA (Devices)·Z-0167-2022·2021-11-03

    GORE CARDIOFORM SEPTAL OCCLUDER Recalled for Incorrect Expiration Date Labeling

    GORE CARDIOFORM SEPTAL OCCLUDER devices are recalled for labeling errors: 95 units marked with 3-year expiration instead of correct 2-year date. Affected units distributed across US and international locations.

    Product
    REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617630 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • ModerateFDA (Devices)·Z-0172-2022·2021-11-03

    Septal Occluder Devices Recalled for Incorrect Expiration Date Labeling

    W L Gore & Associates recalls GORE CARDIOFORM SEPTAL OCCLUDER devices labeled with a 3-year expiration date when the actual shelf life is 2 years. The mislabeling affects 15 units distributed across the United States and internationally.

    Product
    REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0077-2022·2021-10-20

    Gore VIABAHN VBX endoprosthesis recalled for incorrect device dimension labeling

    W L Gore & Associates is recalling GORE VIABAHN VBX balloon expandable endoprosthesis units due to labeling showing incorrect device dimensions. Two units with specification mismatches were distributed to Italy and Lebanon.

    Product
    Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2340-2021·2021-09-01

    Gore Balloon Catheter Leakage Recall Affects 3,364 Units Worldwide

    W.L. Gore is recalling 3,364 units of its Molding & Occlusion Balloon Catheter due to leakage from the guidewire lumen and y-hub that can prevent proper inflation. No injuries have been reported.

    Product
    Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2293-2021·2021-08-25

    Gore Propaten Vascular Graft Pediatric Shunt Diameter Labeling Error

    W L Gore is recalling certain Gore Propaten Vascular Grafts for pediatric shunts due to incorrect diameter labeling. Grafts labeled as 5 mm may actually be 6 mm and vice versa.

    Product
    Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT060015 UDI: (01)00733132606368 HPT060015A UDI: (01)00733132606375
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2292-2021·2021-08-25

    Gore Propaten Vascular Graft Pediatric Shunt Dimension Labeling Error Recall

    W L Gore & Associates is recalling Gore Propaten Vascular Grafts for pediatric shunts due to incorrect diameter labeling: grafts with 6mm inner diameter are labeled 5mm, and those with 5mm diameter are labeled 6mm.

    Product
    Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT050010 UDI: (01)00733132606320 HPT050010A UDI: (01)00733132606337
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1593-2021·2021-05-26

    Gore Viabil Biliary Endoprosthesis Recalled for Length Discrepancy

    W.L. Gore & Associates is recalling 61 Gore Viabil Biliary Endoprosthesis devices because a complaint reported a device appeared shorter than its labeled length.

    Product
    GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0290-2021·2020-11-04

    GORE TAG CONFORMABLE Thoracic Stent Graft Recall for Deployment Issue

    W L Gore is recalling GORE TAG CONFORMABLE Thoracic Stent Grafts because a secondary deployment fiber attachment prevented completion of deployment via the access hatch.

    Product
    GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
    Category
    Medical Device
    Distribution
    Distributed nationwide