# FDA recall Z-1828-2019

> **Covidien LLC** · Class II · device recall initiated 2019-05-17.

## Product

EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT

## Reason for recall

The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.

## Distribution

Nationwide domestic distribution, worldwide foreign distribution.

## Key facts

- **Recall number:** Z-1828-2019
- **Recalling firm:** Covidien LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-05-17
- **Report date:** 2019-06-26

- **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-1828-2019

## Citation

> AI Analytics. FDA recall Z-1828-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1828-2019. Source: US FDA. Licensed CC0.

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