Lutronic XERF EFFECTOR 60 Electrosurgical Units Recalled for Defects

Agency Publication Date: October 14, 2025

Summary

Lutronic Corporation is recalling 7,490 XERF EFFECTOR 60 electrosurgical units due to manufacturing defects in devices produced between April 1, 2025, and August 20, 2025. These defects can lead to rare but serious adverse events for patients during surgical procedures. If you use these devices, contact the manufacturer to arrange for a return, replacement, or correction of the unit.

Risk

The manufacturing defects in the electrosurgical unit could cause the device to malfunction during medical procedures, potentially resulting in injuries or other adverse health events for patients.

What You Should Do

This recall involves the XERF EFFECTOR 60 electrosurgical unit with catalog numbers 1101210000, 1101210100, and 1101210200.
Check your device for serial or lot numbers MP60J25C02, MP60J25G05, MP60J25G06, MP60J25H03, or MP60J25H01 to determine if your unit is affected.
Stop using the recalled device immediately to avoid potential patient harm.
Contact Lutronic Corporation or your medical device distributor to arrange for the return, replacement, or correction of your equipment.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional consumer safety information.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: XERF EFFECTOR 60 Electrosurgical unit

Model / REF:

1101210000

1101210100

1101210200

Serial Numbers:

MP60J25C02

MP60J25G05

MP60J25G06

MP60J25H03

MP60J25H01

UDI:

08809447657752

Date Ranges: Manufactured from 04/01/25 to 08/20/25

Firm initiated recall via letter notification.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97620

Status: Active

Manufacturer: Lutronic Corporation

Sold By: Medical device distributors; Direct clinical sales

Manufactured In: Korea (the Republic of)

Units Affected: 7,490 units

Distributed To: California, Illinois, Massachusetts, New Jersey, New York, Pennsylvania, Texas, Utah

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves the XERF EFFECTOR 60 electrosurgical unit with catalog numbers 1101210000, 1101210100, and 1101210200.

Check your device for serial or lot numbers MP60J25C02, MP60J25G05, MP60J25G06, MP60J25H03, or MP60J25H01 to determine if your unit is affected.

Stop using the recalled device immediately to avoid potential patient harm.

Contact Lutronic Corporation or your medical device distributor to arrange for the return, replacement, or correction of your equipment.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional consumer safety information.