Class II recall Z-0158-2027: W L Gore & Associates, Inc.
Class II recall Z-0158-2027: W L Gore & Associates, Inc. (Arizona): W L Gore & Associates, Inc. Dated 14 days ago, it is in the active follow-up window. Score 68/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 5 related AZ FDAPulse records and the 5-column CSV export.
| 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 |
| Peer records CSV (6 AZ records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-21
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Class II recall Z-0158-2027: W L Gore & Associates, Inc. and 6 Arizona peers
- Arizona FDAPulse records like this one: 6
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Arizona peer: $1,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
68 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 14 days ago.
What is the FDAPulse record for Class II recall Z-0158-2027: W L Gore & Associates, Inc. in Arizona?
Class II device recall Z-0158-2027 by W L Gore & Associates, Inc.: The potential for the devices to be mislabeled with the incorrect length.
How does Class II recall Z-0158-2027: W L Gore & Associates, Inc. compare to other Arizona FDAPulse records?
It is fresh: dated 14 days ago, inside the window where early outreach matters most.
Class II recall Z-0158-2027 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-0158-2027 | AZ | 2026-10-21 |
| Class II recall Z-3155-2026 | MA | 2026-10-07 |
| Class II recall Z-0232-2027 | 2026-10-28 | |
| Class II recall Z-0243-2027 | 2026-10-28 |
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