Ethicon Endo-Surgery Inc: Medical Device Recall in 2021 - (Recall #: Z-2355-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 20, 2021

Date Posted: September 1, 2021

Recall Number: Z-2355-2021

Event ID: 88434

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

Status: Ongoing

Product Quantity: 7870 units

Code Information:

Lot Codes: U95126 U9571N U9526Z U95A80 U9543P U95T0X U9550G GTIN: 10705036015048

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated