Class II

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

W.L. Gore & Associates, Inc. · July 3, 2024

Reason for Recall

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

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

51 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2513-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

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