# Class II recall Z-0158-2027: W L Gore & Associates, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0158-2027 |
| Recalling firm | W L Gore & Associates, Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis;  Model/Catalog Number: VSWVH0808 and VSWVN1006  Product Description: 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. |
| Reason | The potential for the devices to be mislabeled with the incorrect length. |
| Quantity | 32 |
| Distribution | US Nationwide distribution in the states of GA, RI. |
| Recall initiated | 2026-09-03 |
| Reported | 2026-10-21 |
| Firm location | Flagstaff, AZ, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 15 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0158-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.