XERF EFFECTOR 60. Electrosurgical unit.
This recall is currently active, issued October 14, 2025. It was issued by Lutronic Corporation 219 Sowon-Ro; Deogyang Goyang Korea (The Republic Of).
- Recall Initiated
- September 4, 2025
- Posted
- October 14, 2025
- Recall Number
- Z-0146-2026
- Quantity
- 7,490 units
- Official Source
- View on FDA website ↗
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.
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.
Root Cause
Process change control
Action Taken
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.