CLASS II ONGOING Device recall · Reported 19 Aug 2026 · FDA Enforcement Report
Gore Viabil Short Wire Biliary Endoprosthesis recalled
W L Gore & Associates is recalling Gore Viabil Short Wire Biliary Endoprosthesis, distributed nationwide in the US. The recall was initiated on 22 May 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2914-2026
- FDA event ID
- 99143
- Recalling firm
- W L Gore & Associates, Flagstaff, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 May 2026
- FDA classified
- 7 Aug 2026
- Reported
- 19 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 22 May 2026 | Recall initiated by company | |
| 7 Aug 2026 | Classified by FDA | +77 days |
| 19 Aug 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide distribution in the states of GA and RI.
Questions about this recall
Why was it recalled?
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).
Which lots are affected?
Incorrect Catalogue Number/UDI: VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888; Lot Serial No. 30965053, 30965054, 30965055, 30965056, 30965057, 30965058, 30965059, 30965060, 30965061, 30965062, 30965063, 30965064, 30965065.
Where was it sold?
U.S. Nationwide distribution in the states of GA and RI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 99143| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Gore Viabil Short Wire Biliary Endoprosthesis recalled | W L Gore & Associates | Labeling Errors | Nationwide |
More recalls from W L Gore & Associates
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Gore Viabil Short Wire Biliary Endoprosthesis recalled | W L Gore & Associates | Labeling Errors | Nationwide |
| Device | CLASS II | GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component recalled | W L Gore & Associates | Other | Nationwide |
| Device | CLASS II | Gore Acuseal Vascular Graft recalled by W L Gore & Associates | W L Gore & Associates | Packaging Defects | 51 states |
| Device | CLASS II | Heparin, Gore Viabahn VBX, Balloon Expandable recalled | W L Gore & Associates | Sterility | Nationwide |
| Device | CLASS II | Gore Seamguard Bioabsorbable Staple Line Reinforcement recalled | W.L. Gore & Associates | Other | Nationwide |
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