# FDA recall Z-1211-2019

> **COVIDIEN LLC** · Class II · device recall initiated 2019-03-13.

## Product

Covidien Endo Clinch II  Auto  Suture Grasper, 5mm  REF: 174317    The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and is designed for introduction and use through the appropriately sized Covidien" trocar sleeve or larger sized sleeve with the use of a converter. The atraumatic jaws are clamped and locked onto tissue structures by closing the handles

## Reason for recall

Sterilization method used was not consistent with the labeling and the approved sterilization method

## Distribution

Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.

## Key facts

- **Recall number:** Z-1211-2019
- **Recalling firm:** COVIDIEN LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-13
- **Report date:** 2019-05-01
- **Termination date:** 2020-04-23

- **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-1211-2019

## Citation

> AI Analytics. FDA recall Z-1211-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1211-2019. Source: US FDA. Licensed CC0.

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