Summary
The FDA issued a Class II for XERF EFFECTOR 60. Electrosurgical unit. by Lutronic Corporation. Reason: Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients..
Details
Source
Device Recall
External ID
Z-0146-2026
Action Date
2025-10-22
Status
Ongoing
Category
device
Product Description
XERF EFFECTOR 60. Electrosurgical unit.
Lot/Code Info: 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.
Quantity Affected: 7,490 units
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-04
Company
Goyang
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 237 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Lutronic Corporation has 6 FDA actions in our database, including 2 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Lutronic Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Lutronic Corporation have FDA actions?
Lutronic Corporation has 6 FDA actions in our database, including 2 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0146-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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