Ethicon Endo-Surgery Inc recalls HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal therm

Recalled September 1, 2021 · FDA recall Z-2355-2021 · Ethicon Endo-Surgery

Hazard

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 · FDA Class II

Units

7870 units

Sold at

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.

Description

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

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

Manufacturer(s)

Ethicon Endo-Surgery Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →