# FDA recall Z-0908-2018

> **Covidien LLC** · Class II · device recall initiated 2017-09-15.

## 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.

## Distribution

Internationally, including Japan. No USA Customers

## Key facts

- **Recall number:** Z-0908-2018
- **Recalling firm:** Covidien LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-15
- **Report date:** 2018-03-14
- **Termination date:** 2018-12-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Haven, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0908-2018

## Citation

> AI Analytics. FDA recall Z-0908-2018. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-0908-2018. Source: US FDA. Licensed CC0.

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