Recall
FDAHealthSeptember 4, 2025

Lutronic Corporation — XERF EFFECTOR 60. Electrosurgical unit.

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
September 4, 2025

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.

What's affected?

Product
XERF EFFECTOR 60. Electrosurgical unit.
Lot code
MP60J25C02

Additional details

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.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 7,490 units.

View original FDA notice →

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