# FDA recall Z-0002-2021

> **Covidien, LP** · Class II · device recall initiated 2020-08-12.

## Product

Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA  universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

## Reason for recall

The device staples may not properly form upon application preventing adequate hemostasis.  Use of a product with this assembly error may result in incomplete staple formation.

## Distribution

Worldwide distribution - US Nationwide and Global Distribution.

## Key facts

- **Recall number:** Z-0002-2021
- **Recalling firm:** Covidien, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-08-12
- **Report date:** 2020-10-07

- **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-0002-2021

## Citation

> AI Analytics. FDA recall Z-0002-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0002-2021. Source: US FDA. Licensed CC0.

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