# FDA recall Z-0656-2020

> **Ethicon Endo-Surgery Inc** · Class II · device recall initiated 2019-11-07.

## Product

Ligamax 5 mm Endoscopic Multiple Clip Applier

## Reason for recall

A potential exists that certain LIGAMAX devices within  the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility.

## Distribution

US: Nationwide    International: ARGENTINA ARUBA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CHINA COLOMBIA DENMARK ESTONIA FINLAND FRANCE GERMANY INDIA INDONESIA IRELAND JAPAN KOREA KUWAIT MALAYSIA MEXICO NETHERLANDS NEW CALEDONIA NEW ZEALAND PANAMA  PHILIPPINES PUERTO RICO QATAR SAUDI ARABIA SINGAPORE SLOVENIA SWEDEN SWITZERLAND TAIWAN UK

## Key facts

- **Recall number:** Z-0656-2020
- **Recalling firm:** Ethicon Endo-Surgery Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-07
- **Report date:** 2019-12-18
- **Termination date:** 2021-04-23

- **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-0656-2020

## Citation

> AI Analytics. FDA recall Z-0656-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0656-2020. Source: US FDA. Licensed CC0.

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