PlainRecalls

W L Gore & Associates, Inc.

Compiled from official public sources by the editorial team.

28 recalls on record · Latest: Oct 8, 2025

W L Gore & Associates, Inc. Recall Insight

W L Gore & Associates, Inc. appears on 28 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.028% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Oct 8, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 28 entries, severity tagging shows 0 critical, 28 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 28 of 28 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (28). The date window on this page runs from Nov 1, 2017 to Oct 8, 2025.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Oct 8, 2025

GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH06004…

FDA Devices Moderate Sep 11, 2024

Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB051901…

FDA Devices Moderate Sep 11, 2024

Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB055902C, BXB063902C, BXB0659…

FDA Devices Moderate Aug 14, 2024

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;

FDA Devices Moderate Feb 28, 2024

GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number …

FDA Devices Moderate Feb 8, 2023

GORE CARDIOFORM Septal Occluder, REF: GSX0030A

FDA Devices Moderate Nov 2, 2022

GORE CARDIOFORM ASD Occluder. cardiovascular implant.

FDA Devices Moderate Nov 3, 2021

REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx …

FDA Devices Moderate Nov 3, 2021

REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx …

FDA Devices Moderate Nov 3, 2021

REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx …

FDA Devices Moderate Nov 3, 2021

REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx …

FDA Devices Moderate Nov 3, 2021

REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx…

FDA Devices Moderate Nov 3, 2021

REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx…

FDA Devices Moderate Nov 3, 2021

REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx …

FDA Devices Moderate Nov 3, 2021

REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx …

FDA Devices Moderate Nov 3, 2021

REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx …

FDA Devices Moderate Oct 20, 2021

Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 m…

FDA Devices Moderate Sep 1, 2021

Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, C…

FDA Devices Moderate Aug 25, 2021

Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: …

FDA Devices Moderate Aug 25, 2021

Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: …

FDA Devices Moderate May 26, 2021

GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 -…

FDA Devices Moderate Nov 4, 2020

GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

FDA Devices Moderate Nov 4, 2020

GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System

FDA Devices Moderate May 27, 2020

Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending t…

FDA Devices Moderate May 20, 2020

Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flags…

FDA Devices Moderate Feb 12, 2020

GORE¿ EXCLUDER¿ AAA Endoprosthesis

FDA Devices Moderate Feb 12, 2020

GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)

FDA Devices Moderate Nov 1, 2017

GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the d…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare W L Gore & Associates, Inc. with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.