# FDA recall Z-1264-2020

> **COVIDIEN LLC** · Class II · device recall initiated 2020-01-17.

## Product

Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery  Item Code: EGIAUSTND

## Reason for recall

Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection

## Distribution

US Nationwide, Israel, and Japan

## Key facts

- **Recall number:** Z-1264-2020
- **Recalling firm:** COVIDIEN LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-17
- **Report date:** 2020-02-26
- **Termination date:** 2022-07-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mansfield, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1264-2020

## Citation

> AI Analytics. FDA recall Z-1264-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1264-2020. Source: US FDA. Licensed CC0.

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