Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA… — Class II medical device recall Z-0908-2018
Terminated recall by Covidien LLC, reported 2018-03-14. The device cartridge disengaged during use due to manufacturing error.
| Recall number | Z-0908-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, North Haven, CT, United States |
| Recall initiated | 2017-09-15 |
| Classified | 2018-03-05 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2018-12-19 |
| Countries outside the US | JP |
| Quantity | 163 |
| Lot numbers | N6L0351X |
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 for recall
The device cartridge disengaged during use due to manufacturing error.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0908-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.