W L Gore & Associates recalls

W L Gore & Associates has 30 recalls on record with the FDA and USDA, the earliest in 2017 and the latest reported on 19 Aug 2026. 24 are still ongoing. 4 were reported in the last 12 months. The most frequent reason is sterility.

Total recalls30since 2017

Last 12 months4reported

Class I00% of total

Ongoing24latest 19 Aug 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 1Oct 0 0 0Jan '26 0 0 0Apr 0 0 1Jul 2 0

Severity split

Class I 0 0%Class II 30 100%Class III 0 0%

Why w l gore & associates is recalled

Product types

By year

2026310%
202513%
2024310%
202313%
202213%
20211447%
2020620%
201713%

Ongoing w l gore & associates recalls

24 active

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Device	CLASS II	Gore Viabil Short Wire Biliary Endoprosthesis recalled	W L Gore & Associates	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Gore Viabil Short Wire Biliary Endoprosthesis recalled	W L Gore & Associates	Labeling Errors	Nationwide
8 Jul 2026Device	CLASS II	GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component recalled	W L Gore & Associates	Other	Nationwide
8 Oct 2025Device	CLASS II	Gore Acuseal Vascular Graft recalled by W L Gore & Associates	W L Gore & Associates	Lead & Heavy Metals	51 states
11 Sep 2024Device	CLASS II	Heparin, Gore Viabahn VBX, Balloon Expandable recalled	W L Gore & Associates	Sterility	Nationwide
14 Aug 2024Device	CLASS II	Gore Seamguard Bioabsorbable Staple Line Reinforcement recalled	W.L. Gore & Associates	Other	Nationwide

All w l gore & associates recalls, newest first

30 total

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Device	CLASS II	Gore Viabil Short Wire Biliary Endoprosthesis recalled	W L Gore & Associates	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Gore Viabil Short Wire Biliary Endoprosthesis recalled	W L Gore & Associates	Labeling Errors	Nationwide
8 Jul 2026Device	CLASS II	GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component recalled	W L Gore & Associates	Other	Nationwide
8 Oct 2025Device	CLASS II	Gore Acuseal Vascular Graft recalled by W L Gore & Associates	W L Gore & Associates	Lead & Heavy Metals	51 states
11 Sep 2024Device	CLASS II	Heparin, Gore Viabahn VBX, Balloon Expandable recalled	W L Gore & Associates	Sterility	Nationwide
14 Aug 2024Device	CLASS II	Gore Seamguard Bioabsorbable Staple Line Reinforcement recalled	W.L. Gore & Associates	Other	Nationwide
28 Feb 2024Device	CLASS II	Gore Viabil Short Wire Biliary Endoprosthesis, Product labeled as recalled	W.L. Gore & Associates	Labeling Errors	Nationwide
8 Feb 2023Device	CLASS II	Gore Cardioform Septal Occluder recalled by W L Gore & Associates	W L Gore & Associates	Device Malfunction	Nationwide
2 Nov 2022Device	CLASS II	Gore Cardioform Asd Occluder recalled by W L Gore & Associates	W L Gore & Associates	Other	Nationwide
3 Nov 2021Device	CLASS II	REF/Catalogue Number GSXE0025, Gore Cardioform Septal Occluder 25 mm recalled	W L Gore & Associates	Sterility	47 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.