# FDA recall Z-0200-2020

> **Ethicon Endo-Surgery Inc** · Class I · device recall initiated 2019-10-03.

## Product

ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A

## Reason for recall

The staplers may contain an out of specification anvil component within the jaw of the device.  This condition may lead to malformed staples, which can compromise staple line integrity.  If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.

## Distribution

Worldwide distribution.  US Nationwide.  Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore.

## Key facts

- **Recall number:** Z-0200-2020
- **Recalling firm:** Ethicon Endo-Surgery Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-03
- **Report date:** 2019-11-06
- **Termination date:** 2021-06-03

- **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-0200-2020

## Citation

> AI Analytics. FDA recall Z-0200-2020. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-0200-2020. Source: US FDA. Licensed CC0.

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