FDAClass IIOctober 22, 2025

XERF EFFECTOR 60. Electrosurgical unit recall

XERF EFFECTOR 60. Electrosurgical unit.

Why was XERF EFFECTOR 60. Electrosurgical unit recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
XERF EFFECTOR 60. Electrosurgical unit.
Recalling firm
Lutronic Corporation
Quantity
7,490 units
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.
Recall date
October 22, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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