# FDA recall Z-1322-2022

> **Covidien, LP** · Class II · device recall initiated 2022-05-13.

## Product

EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.

## Reason for recall

The affected staplers have the potential for the staple guide to not be securely attached to the instrument. The issue could cause the component to disengage and if disengaged, could allow the device to transect tissue without forming staples.

## Distribution

Worldwide distribution - US Nationwide.

## Key facts

- **Recall number:** Z-1322-2022
- **Recalling firm:** Covidien, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-05-13
- **Report date:** 2022-07-13

- **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-1322-2022

## Citation

> AI Analytics. FDA recall Z-1322-2022. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-1322-2022. Source: US FDA. Licensed CC0.

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