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.

26–31 of 31

  • HighFDA (Devices)·Z-0291-2021·2020-11-04

    GORE TAG Stent Graft Recalled Due to Delivery Catheter Removal Issue

    W.L. Gore is recalling GORE TAG stent grafts because the delivery catheter could not be withdrawn after implantation.

    Product
    GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2052-2020·2020-05-27

    W L Gore Recalls 15 Thoracic Stent Grafts Due to Labeling Error

    W L Gore & Associates is recalling 15 Conformable Thoracic Stent Grafts distributed in Japan because incorrect labels were placed on the primary and secondary packaging.

    Product
    Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1962-2020·2020-05-20

    Gore DrySeal Flex Introducer Sheath Recalled for Incorrect Size Labeling

    W. L. Gore & Associates is recalling 141 Gore DrySeal Flex Introducer Sheaths because 16Fr devices were mislabeled as 14Fr.

    Product
    Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0995-2020·2020-02-12

    Gore Excluder AAA Endoprosthesis Recalled for Catheter Separation

    W. L. Gore & Associates is recalling GORE EXCLUDER AAA Endoprosthesis devices due to reports of leading end catheter component separations.

    Product
    GORE¿ EXCLUDER¿ AAA Endoprosthesis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0048-2018·2017-11-01

    GORE TAG Thoracic Endoprosthesis Recalled for Incomplete Deployment Risk

    W.L. Gore & Associates is recalling 12,197 GORE TAG Thoracic Endoprosthesis units worldwide due to a risk of incomplete or partial deployment during endovascular procedures.

    Product
    GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.
    Category
    Medical Device
    Distribution
    0 states