United StatesThe recall affects the XERF EFFECTOR 60 electrosurgical unit (Model/Catalog numbers 1101210000, 1101210100, 1101210200; UDI 08809447657752; SERIAL/LOT MP60J25C02, MP60J25G05, MP60J25G06, MP60J25H03, MP60J25H01) manufactured from 04/01/25 to 08/20/25. Lutronic Corporation initiated the recall because manufacturing defects in devices from that production period can, on rare occasions, result in adverse events for patients; these units were distributed worldwide, including U.S. states CA, IL, MA, NJ, NY, PA, TX, and UT.
What's being recalled
XERF EFFECTOR 60. Electrosurgical unit.
Recalling firm: Lutronic Corporation, Goyang, Korea (the Republic of).
How to identify it
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.
The hazard
Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)