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U.S. Department of Health and Human Services

Class 2 Device Recall XERF EFFECTOR 60

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 Class 2 Device Recall XERF EFFECTOR 60see related information
Date Initiated by FirmSeptember 04, 2025
Date PostedOctober 14, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0146-2026
Recall Event ID 97620
510(K)NumberK251327 
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
ProductXERF EFFECTOR 60. Electrosurgical unit.
Code Information 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.
Recalling Firm/
Manufacturer		 Lutronic Corporation
219 Sowon-Ro; Deogyang
Goyang Korea (the Republic of)
For Additional Information ContactCustomer Service
1-800-8862966
Manufacturer 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.
FDA Determined
Cause 2		Process change control
ActionAn 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.
Quantity in Commerce7,490 units
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GEI
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