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Lutronic Corporation recalls XERF EFFECTOR 60. Electrosurgical unit.
Recalled October 22, 2025 · FDA recall Z-0146-2026 · Lutronic
Hazard
Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients. · FDA Class II
Units
7,490 units
Sold at
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.
Description
Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.
Product
XERF EFFECTOR 60. Electrosurgical unit.
Manufacturer(s)
Lutronic Corporation
Made in
Korea (the Republic of)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →