Class II

Medical Device Recall: XERF EFFECTOR 60. Electrosurgical unit.

Lutronic Corporation · September 4, 2025

Reason for Recall

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

Distribution

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.

States Affected

NATIONWIDE

Quantity Affected

7,490 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0146-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.