Lower riskMedical device recall · FDA · Published September 3, 2026
GORE VIABIL Short Wire Biliary Endoprosthesis Risk of Mislabeling
W L Gore recalls 32 units of GORE VIABIL Short Wire Biliary Endoprosthesis (models VSWVH0808 and VSWVN1006) due to potential mislabeling with incorrect length.
“GORE VIABIL Short Wire Biliary Endoprosthesis Risk of Mislabeling.” GovInfoNow, updated October 27, 2026. https://govinfonow.com/recall/1764700-w-l-gore-associates-inc-recalls-generic-name-gore-viabil. Based on FDA recall #Z-0158-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0158-2027%22&limit=1).
W L Gore & Associates, Inc. recalled GORE VIABIL Short Wire Biliary Endoprosthesis devices due to potential mislabeling with incorrect lengths, the FDA said on Sept. 3, 2026. The voluntary Class II recall affects 32 units distributed in Georgia and Rhode Island.
How to tell if you have it
Brand: W L Gore
Product: GORE VIABIL Short Wire Biliary Endoprosthesis
Lot Serial Numbers for VSWVN1006: 30843556, 30843557, 30843558, 30843559, 30843560, 30843561, 30843562, 30843563, 30843564, 30843565, 30843566, 30843567, 30843568, 30843569, 30843570, 30843571
Distribution: US Nationwide in GA and RI
The hazard
The devices may be mislabeled with the incorrect length. The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct.
Context
GovInfoNow's records show W L Gore & Associates, Inc. has 19 other recalls on record since Sept. 25, 2017. Other recent recalls of similar products include BD InLay Optima Ureteral Stent Kit labeling discrepancy risk (Nov. 6, 2025), BD InLay Optima Ureteral Stent Kit label size mismatch risk (Nov. 6, 2025), and Bard Ureteral Stent Kit recall label size mismatch risk (Nov. 6, 2025).
How to tell if you have this one
Check for model numbers VSWVH0808 or VSWVN1006 on the device packaging. The lot serial numbers listed in the recall include specific sequences like 30907025 through 30907038 for the first model and 30843556 through 30843571 for the second model.
Brand
W L Gore
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Label
Look for model numbers VSWVH0808 or VSWVN1006 on the device packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of GA, RI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Georgia, Rhode Island.
Recall timeline
FDA published this recall 48 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0158-2027 (September 3, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0158-2027 to see it in context.
Plain-language summary written by qwen3:4b on October 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.