GORE VIABIL Short Wire Biliary Endoprosthesis — Class II medical device recall Z-2914-2026
Ongoing recall by W L Gore & Associates, Inc., reported 2026-08-19, distributed nationwide. 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm
| Recall number | Z-2914-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | W L Gore & Associates, Inc., Flagstaff, AZ, United States |
| Recall initiated | 2026-05-22 |
| Classified | 2026-08-07 |
| Reported by FDA | 2026-08-19 |
| Distributed | Nationwide (US) |
| Quantity | 13 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00733132638888 |
| Serial numbers | 30965053, 30965054, 30965055, 30965056, 30965057, 30965058, 30965059, 30965060, 30965061, 30965062, 30965063, 30965064, 30965065 |
| Model numbers | VSWVN1010 |
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.
Reason for recall
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2914-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.