# FDA recall Z-0070-2019

> **COVIDIEN LLC** · Class II · device recall initiated 2018-08-17.

## Product

EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT	TRIEEA28XT	TRIEEA31MT	TRIEEA31XT    Product Usage:  The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.

## Reason for recall

The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma. There have been no reports of serious injury related to this issue.

## Distribution

Worldwide Distribution - US Nationwide in the states of CA, FL, IL, NC, NY, UT. and the countries of Austria, Belgium, Denmark, Finland, France, Germany, Iceland, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Reunion, Spain, Sweden, Switzerland, and United Kingdom.

## Key facts

- **Recall number:** Z-0070-2019
- **Recalling firm:** COVIDIEN LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-17
- **Report date:** 2018-10-10
- **Termination date:** 2020-04-10

- **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-0070-2019

## Citation

> AI Analytics. FDA recall Z-0070-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0070-2019. Source: US FDA. Licensed CC0.

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