Lutronic Corporation recalls XERF EFFECTOR 60. Electrosurgical unit.

Recall date

September 4, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0146-2026

FDA classification

Class II

Brand / firm

Lutronic Corporation

Sold / distributed

Worldwide - US Nationwide distribution in the states of CA, IL, MA, NJ, NY, PA, TX, and UT. The countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.

Why it was recalled

Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

XERF EFFECTOR 60. Electrosurgical unit.