W.L. Gore & Associates, Inc. recalls GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;

Recall date

July 3, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2513-2024

FDA classification

Class II

Brand / firm

W.L. Gore & Associates, Inc.

Sold / distributed

US Nationwide distribution in the states of CA, GA, IL, NC, OH, OK, WA.

Why it was recalled

Devices were labeled with an expiration date of four years and ten days rather than the validated two years.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;