W L Gore & Associates, Inc. recalls Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The…
The potential for the devices to be mislabeled with the incorrect length.
Read the official notice →- Date
- 2026-10-21
- Country
- United States
- Brand
- W L Gore & Associates
- Product
- Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The GORE…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of GA, RI.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More W L Gore & Associates recalls
- 2026-08-19
W L Gore & Associates, Inc. recalls GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain…
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).
FDA · DeviceW L Gore & Associates, Inc.U.S. Nationwide distribution in the states of GA and RI.Official notice →- 2026-07-08
W L Gore & Associates, Inc. recalls GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and…
Due to catheter separation
FDA · DeviceW L Gore & Associates, Inc.Worldwide - U.S. Nationwide distribution including in the states and…Official notice →- 2025-10-08
W L Gore & Associates, Inc. recalls GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W,…
Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to…
FDA · DeviceW L Gore & Associates, Inc.US: OR, AL, OH, MD, VA, CA, FL, NC, OK, MA, MO, AZ, TX, IL, GA, PA, NH, HI,…Official notice →- 2024-09-11
W L Gore & Associates, Inc. recalls Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A…
Due to packaging defects, sterility assurance and heparin activity may be compromised.
FDA · DeviceW L Gore & Associates, Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice →- 2024-08-14
W.L. Gore & Associates, Inc. recalls GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
FDA · DeviceW.L. Gore & Associates, Inc.US Nationwide distribution in the states of CA, GA, IL, NC, OH, OK, WA.Official notice →- 2024-02-28
W.L. Gore & Associates, Inc. recalls GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2)…
Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, unplanned device removal, secondary…
FDA · DeviceW.L. Gore & Associates, Inc.US Nationwide distribution in the state of Georgia.Official notice →
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