Device recall

Z-2513-2024: GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular…

FDA device recall · Class II · W.L. Gore & Associates, Inc.

Key facts

Recall number (Z-number) Z-2513-2024
Recall event 94976
Product GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
Product code FTL
Recalling firm W.L. Gore & Associates, Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K053200
FEI number 3003910212

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)