FDA recall, , Moderate risk
Gore Viabil Short Wire Biliary Endoprosthesis
The Gore Viabil Short Wire Biliary Endoprosthesis may be mislabeled with the incorrect length.
Summary by Recall Canary from the FDA notice
What happened
W L Gore & Associates, Inc. began a recall on September 3, 2026, of the GORE VIABIL Short Wire Biliary Endoprosthesis, a flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct, due to the potential for the devices to be mislabeled with the incorrect length. The recall was added to the FDA's Enforcement Report and classified by the FDA on October 14, 2026, with US Nationwide distribution in the states of Georgia and Rhode Island.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number, UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Gore Viabil Short Wire Biliary Endoprosthesis
- Model number
- VSWVH0808
- VSWVN1006
- UDI-DI
- 00733132638772
- 00733132638864
- Lot code
- 30907025
- 30907033
- 30907034
- 30907036
- 30907023
- 30907024
- 30907026
- 30907027
- 30907028
- 30907029
- 30907030
- 30907031
- 30907032
- 30907035
- 30907037
- 30907038
- 30843556
- 30843557
- 30843558
- 30843559
- 30843560
- 30843561
- 30843562
- 30843563
- 30843564
- 30843565
- 30843566
- 30843567
- 30843568
- 30843569
- 30843570
- 30843571
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Georgia, Rhode Island.
- Company
- W L Gore & Associates, Inc.
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99873
- Recall number
- Z-0158-2027
All recalls from W L Gore & Associates, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
