FDA Device recall Z-0908-2018
Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or mini…
- FDA Device
- Class II
- terminated
- Published 2018-03-14
On 2018-03-14 the FDA classified a Class II recall of Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or mini… by Covidien, citing the device cartridge disengaged during use due to manufacturing error.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0908-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-15 |
| Published | 2018-03-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Covidien |
| Distribution | n/a |
Product
Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, e.g. low anterior resection. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Reason
The device cartridge disengaged during use due to manufacturing error.
Identifiers
| code_info | Product number: EGIARADXT Lot code: N6L0351X |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0908-2018%22
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