# FDA recall Z-0636-2018

> **Covidien LLC** · Class II · device recall initiated 2017-09-13.

## Product

Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

## Reason for recall

Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time.

## Distribution

Nationally

## Key facts

- **Recall number:** Z-0636-2018
- **Recalling firm:** Covidien LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-13
- **Report date:** 2018-02-28
- **Termination date:** 2019-06-28

- **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-0636-2018

## Citation

> AI Analytics. FDA recall Z-0636-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0636-2018. Source: US FDA. Licensed CC0.

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