Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2915-2026·Announced 2026-08-19

GORE VIABIL Biliary Endoprosthesis Recalled for Incorrect Labeling

W L Gore & Associates is recalling 13 GORE VIABIL Short Wire Biliary Endoprostheses because they were incorrectly labeled with the wrong model number and dimensions.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (incorrect model number and dimensions) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

W L Gore & Associates, Inc. is recalling 13 units of the GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. The recall was initiated because the devices were incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (Model No. VSWVN1010). The actual recalled devices are 10 mm diameter x 7 cm with transmural drainage holes (Model No. VSWVH1006).

The affected units were distributed nationwide in the states of Georgia and Rhode Island. The incorrect labeling involves the Catalogue Number/UDI and Lot Serial Numbers. The specific lot serial numbers affected are 30970948 through 30970960.

Healthcare providers and facilities should check their inventory for these specific lot numbers and model designations. If the devices are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations. This recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.

The recalled product

Product: GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed.
Manufacturer: W L Gore & Associates, Inc.
Category: Medical Device — Biliary Endoprosthesis
Hazard: mis-labeling
Affected units: 13

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

Incorrect Catalogue Number/UDI: VSWVH1006 / 00733132638796
VSWVH1006 / 00733132638796
Lot Serial No. 30970948
30970949
30970950
30970951
30970952
30970953
30970954
30970955
30970956
30970957
30970958
30970959
30970960.

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Same manufacturer · W L Gore & Associates, Inc.

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Same hazard · mis labeling