FDA Device recall Z-2505-2018
Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA60AXT
- FDA Device
- Class II
- ongoing
- Published 2018-07-25
On 2018-07-25 the FDA classified a Class II recall of Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA60AXT by Covidien Medtronic, citing device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2505-2018 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-05-22 |
| Published | 2018-07-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Covidien Medtronic |
| Distribution | US |
Product
Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA60AXT
Reason
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Identifiers
| code_info | N7L0974KX, N7M0486KX, N7M0762KX & N8A0363KX |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2505-2018%22
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