Home / Recalls / Lutronic Corporation / Z-0146-2026

Z-0146-2026 Class II Ongoing

Recalled by Lutronic Corporation — Goyang

Recall Details

Product Type: Devices
Report Date: October 22, 2025
Initiation Date: September 4, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7,490 units

Product Description

XERF EFFECTOR 60. Electrosurgical unit.

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 Pattern

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.

Code Information

Model/Catalog Number: 1101210000, 1101210100, 1101210200; UDI: 08809447657752, SERIAL/LOT: MP60J25C02, MP60J25G05, MP60J25G06, MP60J25H03, and MP60J25H01. Devices manufactured from 04/01/25 to 08/20/25.