# FDA recall Z-2355-2021

> **Ethicon Endo-Surgery Inc** · Class II · device recall initiated 2021-07-20.

## Product

HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.  Product Code: HARHD20

## Reason for recall

An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Austria, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czechia,  Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Ireland,  Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico,  Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Sweden,  Switzerland, Taiwan, Thailand, Turkey, United  Kingdom, United Arab Emirates.

## Key facts

- **Recall number:** Z-2355-2021
- **Recalling firm:** Ethicon Endo-Surgery Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-07-20
- **Report date:** 2021-09-01

- **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-2355-2021

## Citation

> AI Analytics. FDA recall Z-2355-2021. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-2355-2021. Source: US FDA. Licensed CC0.

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