# FDA recall Z-1850-2018

> **COVIDIEN MEDTRONIC** · Class II · device recall initiated 2018-04-26.

## Product

MGBX ZESTAW GB LS X1    Product Usage:  The Endo GIA  universal and Endo GIA  universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA  universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.

## Reason for recall

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.

## Distribution

Worldwide and US Nationwide

## Key facts

- **Recall number:** Z-1850-2018
- **Recalling firm:** COVIDIEN MEDTRONIC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-26
- **Report date:** 2018-05-23
- **Termination date:** 2020-06-17

- **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-1850-2018

## Citation

> AI Analytics. FDA recall Z-1850-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-1850-2018. Source: US FDA. Licensed CC0.

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