FDA Device recall Z-2513-2024
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm
- FDA Device
- Class II
- ongoing
- Published 2024-08-14
On 2024-08-14 the FDA classified a Class II recall of GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm by W L Gore And Associates, citing devices were labeled with an expiration date of four years and ten days rather than the validated two years.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2513-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-03 |
| Published | 2024-08-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | W L Gore And Associates |
| Distribution | US |
Product
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
Reason
Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
Identifiers
| code_info | Catalog Number: 1BSGC25; UDI-DI: 00733132600755; Lot number: 26590654; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2513-2024%22
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