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W. L. Gore & Associates, Inc

Also registered as W.L. Gore & Associates

United Statesfrom the FDA registration address FDA establishment FEI 2017233

Site of W. L. Gore & Associates, Inc.

Devices
3
Registrations
FDA
FDA recalls
3424 ongoing since 2021 (26 open in total)
2 open since before 2021

What W. L. Gore & Associates, Inc makes

The company manufactures drug-coated and non-medicated endovascular stent-grafts for peripheral arteries and the aortoiliac region, synthetic vascular grafts for bypass procedures, and polymer-metal biliary stents for bile duct obstruction. It also produces monofilament sutures made from polyolefin/fluoropolymer blends, nonimplantable vascular catheter introduction sets, and bioabsorbable synthetic polymer surgical mesh for extra-gynaecological applications.

The portfolio includes devices classified as Class II and Class III under FDA regulations, all listed in the FDA’s Unique Device Identifier (UDI) database. The company is headquartered in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue3

Newest first, rows 1-3 of 3

Company details

FDA FEI number
2017233
Address
1505 NORTH FOURTH ST., FLAGSTAFF, AZ, 86004

FDA recalls34

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 32 recalls initiated by W. L. GORE & ASSOCIATES, INC, the earliest on 2017-09-25 and the most recent on 2026-09-03. By recorded status: 26 ongoing and 6 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 1
  • 2018 0
  • 2019 2
  • 2020 4
  • 2021 14
  • 2022 2
  • 2023 0
  • 2024 4
  • 2025 1
  • 2026 4

2 initiated before 2017

Showing the 10 most recent of 34 recalls.

  • 2026

    • 3 Sep 2026 Z-0158-2027 Class II Ongoing The potential for the devices to be mislabeled with the incorrect length. Distribution: US Nationwide distribution in the states of GA, RI. Submission number: K170740
    • 22 May 2026 Z-2914-2026 Class II Ongoing 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010). Distribution: U.S. Nationwide distribution in the states of GA and RI. Submission number: K170740
    • 22 May 2026 Z-2915-2026 Class II Ongoing 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010). Distribution: U.S. Nationwide distribution in the states of GA and RI. Submission number: K170740
    • 19 May 2026 Z-2672-2026 Class II Ongoing Due to catheter separation Distribution: Worldwide - U.S. Nationwide distribution including in the states and territories of AL, AR, AZ, CA, CO, CT, DC, DE, FL,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states and territories of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, and WI. The countries of United Arab Emirates, Australia, Austria, Canada, Switzerland, China, Cyprus, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Israel, Italy, Japan, Luxembourg, Monaco, Malta, Netherlands, Norway, New Zealand, Poland, Portugal, Saudi Arabia, Slovakia, Sweden, and Taiwan.
      Submission number: P210032

  • 2025

    • 26 Aug 2025 Z-0036-2026 Class II Ongoing Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to modify existing warning to 1) further clarify techniques that may contribute to the risk of delamination, 2) Addition of delamination to device-related adverse event section. Distribution: US: OR, AL, OH, MD, VA, CA, FL, NC, OK, MA, MO, AZ, TX, IL, GA, PA, NH, HI, MN, MS, KY, ID, LA, NJ, TN, DE, IN, MI, WI,…
      Full distribution text US: OR, AL, OH, MD, VA, CA, FL, NC, OK, MA, MO, AZ, TX, IL, GA, PA, NH, HI, MN, MS, KY, ID, LA, NJ, TN, DE, IN, MI, WI, NY, DC, SC, CT, NE, IA, WA, AR, NV, WV, AK, UT, ND, KS, CO, ME, MT, NM, SD, PR, WY, RI. OUS: PANAMA, CANADA, CHINA, TAIWAN, GERMANY, SLOVENIA, NORWAY, UNITED KINGDOM, ITALY, SPAIN, FINLAND, NETHERLANDS, SWEDEN, FRANCE, UNITED ARAB EMIRATES, DENMARK, PORTUGAL, AUSTRIA, SWITZERLAND, BELGIUM, TURKIYE, SLOVAK REPUBLIC, CYPRUS, SAUDI ARABIA, SOUTH AFRICA, LUXEMBOURG, FRENCH GUIANA, ANDORRA, IRELAND, NEW CALEDONIA, POLAND, ISRAEL, GREECE, GUADELOUPE, CROATIA, REUNION, BAHRAIN, HUNGARY, JAPAN
      Submission number: K233551

  • 2024

    • 3 Jul 2024 Z-2513-2024 Class II Ongoing Devices were labeled with an expiration date of four years and ten days rather than the validated two years. Distribution: US Nationwide distribution in the states of CA, GA, IL, NC, OH, OK, WA. Submission number: K053200
    • 1 Jul 2024 Z-2945-2024 Class II Ongoing Due to packaging defects, sterility assurance and heparin activity may be compromised. Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Japan.
    • 1 Jul 2024 Z-2946-2024 Class II Ongoing Due to packaging defects, sterility assurance and heparin activity may be compromised. Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Japan.
    • 19 Jan 2024 Z-1179-2024 Class II Ongoing Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, unplanned device removal, secondary procedure, cholangitis, cholecystitis, and/or pain. The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. The endoprosthesis is radially compressed and secured onto the distal end of a catheter-based delivery system for deployment. The catheter provides a means for accessing and implanting the GORE VIABIL Short Wire Biliary Endoprosthesis at the target site in the biliary tract. Distribution: US Nationwide distribution in the state of Georgia. Submission number: K170740

  • 2022

    • 14 Dec 2022 Z-1048-2023 Class II Ongoing Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could potentially result could result in occluder embolization, anoxic brain injury, central venous or arterial perforation or rupture. Distribution: US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA, MO, SD, VA.
Show the 25 most recent of 34 recalls

  • 2022

    • 21 Sep 2022 Z-0136-2023 Class II Ongoing Due to manufacturing records (Release Test Results) indicating "Failed". Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GA, IA, ID, IL, ME,…
      Full distribution text Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GA, IA, ID, IL, ME, MN, NC, NY, JPA, TN, TX, WA, and WI. The countries of Denmark, and Japan.

  • 2021

    • 7 Sep 2021 Z-0077-2022 Class II Ongoing Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device. Distribution: International distribution to the countries of Italy & Lebanon. Submission number: P160021
    • 2 Sep 2021 Z-0164-2022 Class II Ongoing Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. Distribution: US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ,…
      Full distribution text US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ, NM,NV,NY,OH,OK,OR,PA,SC,SD,TN,TX,UT,VA,VT,WA,WI, WV OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE
      Submission number: P050006S044
    • 2 Sep 2021 Z-0165-2022 Class II Ongoing Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. Distribution: US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ,…
      Full distribution text US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ, NM,NV,NY,OH,OK,OR,PA,SC,SD,TN,TX,UT,VA,VT,WA,WI, WV OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE
      Submission number: P050006S044
    • 2 Sep 2021 Z-0166-2022 Class II Ongoing Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. Distribution: US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ,…
      Full distribution text US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ, NM,NV,NY,OH,OK,OR,PA,SC,SD,TN,TX,UT,VA,VT,WA,WI, WV OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE
      Submission number: P050006S044
    • 2 Sep 2021 Z-0167-2022 Class II Ongoing Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. Distribution: US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ,…
      Full distribution text US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ, NM,NV,NY,OH,OK,OR,PA,SC,SD,TN,TX,UT,VA,VT,WA,WI, WV OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE
      Submission number: P050006S044
    • 2 Sep 2021 Z-0168-2022 Class II Ongoing Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. Distribution: US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ,…
      Full distribution text US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ, NM,NV,NY,OH,OK,OR,PA,SC,SD,TN,TX,UT,VA,VT,WA,WI, WV OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE
      Submission number: P050006S044
    • 2 Sep 2021 Z-0169-2022 Class II Ongoing Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. Distribution: US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ,…
      Full distribution text US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ, NM,NV,NY,OH,OK,OR,PA,SC,SD,TN,TX,UT,VA,VT,WA,WI, WV OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE
      Submission number: P050006S044
    • 2 Sep 2021 Z-0170-2022 Class II Ongoing Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. Distribution: US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ,…
      Full distribution text US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ, NM,NV,NY,OH,OK,OR,PA,SC,SD,TN,TX,UT,VA,VT,WA,WI, WV OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE
      Submission number: P050006S044
    • 2 Sep 2021 Z-0171-2022 Class II Ongoing Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. Distribution: US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ,…
      Full distribution text US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ, NM,NV,NY,OH,OK,OR,PA,SC,SD,TN,TX,UT,VA,VT,WA,WI, WV OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE
      Submission number: P050006S044
    • 2 Sep 2021 Z-0172-2022 Class II Ongoing Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. Distribution: US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ,…
      Full distribution text US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ, NM,NV,NY,OH,OK,OR,PA,SC,SD,TN,TX,UT,VA,VT,WA,WI, WV OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE
      Submission number: P050006S044
    • 12 Jul 2021 Z-2340-2021 Class II Ongoing Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or an inability to inflate. Distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID,…
      Full distribution text Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of AUS, CAN, CHE, DEU, DNK, ESP, FIN, FRA, GBR, GRC, HRV, HUN, IRL, ISR, ITA, JPN, MEX, NLD, NOR, POL, PRT, SMR, SWE.
      Submission number: K172567
    • 12 May 2021 Z-2292-2021 Class II Ongoing Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm. Distribution: US: NE, DC, MA, KY, IL, WA, MD, CA, AZ, GA OUS: Canada, Brazil, Europe, Saudi Arabia Submission number: K062161
    • 12 May 2021 Z-2293-2021 Class II Ongoing Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm. Distribution: US: NE, DC, MA, KY, IL, WA, MD, CA, AZ, GA OUS: Canada, Brazil, Europe, Saudi Arabia Submission number: K062161
    • 5 Apr 2021 Z-1593-2021 Class II Terminated The Gore post market surveillance team received a complaint that a GORE VIABIL Biliary Endoprosthesis appeared shorter than the labeled length. Distribution: Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, HI, IL, KS, MD, MN, NE, NY,…
      Full distribution text Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, HI, IL, KS, MD, MN, NE, NY, OK, RI, TX, VA and the countries of Portugal, Italy.
      Submission number: K081184

Frequently asked questions

How many devices does W. L. GORE & ASSOCIATES, INC have in the registry?

The registry currently lists 3 devices for W. L. GORE & ASSOCIATES, INC. Devices recorded under merged duplicate company entries are counted once.

Which registries list W. L. GORE & ASSOCIATES, INC's devices?

Among its 3 most recently registered devices, W. L. GORE & ASSOCIATES, INC has devices listed in FDA 510(k) (3 devices).

What risk classes do W. L. GORE & ASSOCIATES, INC's devices fall under?

Among its 3 most recently registered devices, the classes recorded for W. L. GORE & ASSOCIATES, INC's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for W. L. GORE & ASSOCIATES, INC?

FDA recall records list 34 recalls initiated by W. L. GORE & ASSOCIATES, INC, the most recent initiated on 3 Sep 2026. 26 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from W. L. GORE & ASSOCIATES, INC in the registry?

The most recently registered devices listed for W. L. GORE & ASSOCIATES, INC include GORE(R) EMBOLIC FILTER, GORE HYBRID VASCULAR GRAFT and GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company.