# FDA recall Z-2326-2021

> **Ethicon Endo-Surgery Inc** · Class II · device recall initiated 2021-06-03.

## Product

ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures.  Product Code: PSEE60A

## Reason for recall

Mislabeled: Labeled on the package as 60mm contains  45mm devices

## Distribution

Worldwide distribution - US Nationwide distribution in the states of MD, WA and the countries of Belgium, China, Denmark, Estonia, France, Germany, Italy, Japan, Korea,  Latvia, Lithuania, Netherlands, Poland, Portugal, Russia, Spain, Sweden, Switzerland,  United Kingdom.

## Key facts

- **Recall number:** Z-2326-2021
- **Recalling firm:** Ethicon Endo-Surgery Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-03
- **Report date:** 2021-08-25
- **Termination date:** 2022-09-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Blue Ash, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2326-2021

## Citation

> AI Analytics. FDA recall Z-2326-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2326-2021. Source: US FDA. Licensed CC0.

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