FDA Device recall Z-2504-2018
Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-StapleTechnology, Item Code EGIA60AMT
- 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 Articulating Medium/Thick Reload with Tri-StapleTechnology, Item Code EGIA60AMT 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-2504-2018 |
| 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 Articulating Medium/Thick Reload with Tri-StapleTechnology, Item Code EGIA60AMT
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 | N7L0711KX, N7L1141KX, N7M0853KX, N8B0419KX, N7L0912KX, N7M0241KX, N8A0271KX, N8C0012KX, N7L0973KX, N7M0353KX, N8A0684…N7L0711KX, N7L1141KX, N7M0853KX, N8B0419KX, N7L0912KX, N7M0241KX, N8A0271KX, N8C0012KX, N7L0973KX, N7M0353KX, N8A0684KX, N8C0143KX, N7L1038KX, N7M0366KX, N8A0924KX, N7M0996KX, N7L0807KX, N7M0548KX, N8A1143KX, N8A0173KX, N7L1050KX, N7M0617KX, N8B0161KX, N8A0488KX, N7L1125KX, N7M0745KX, N8B0283KX & N8C0136KX |
|---|
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-2504-2018%22
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