XERF EFFECTOR 60 (Lutronic) – Manufacturing Defects (2025)
Manufacturing defects may potentially result in rare adverse patient events.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
XERF EFFECTOR 60. Electrosurgical unit.
Brand
Lutronic Corporation 219 Sowon-Ro; Deogyang Goyang Korea (the Republic of)
Lot Codes / Batch Numbers
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.
Products Sold
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.
Lutronic Corporation 219 Sowon-Ro; Deogyang Goyang Korea (the Republic of) is recalling XERF EFFECTOR 60. Electrosurgical unit. due to Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.
Recommended Action
Per FDA guidance
An URGENT-Field Safety Corrective Action - XERF Tips notification dated 9/4/25 was mailed to consignees notifying them of this recall. Consignees are instructed to immediately stop use of affected devices and to return all units utilizing the provided shipping label. Consignees with any questions can contact Customer Service at 1-800-886-2966 or by email at serviceadmin@cynosure.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026