Lutronic Corporation recalls XERF EFFECTOR 60. Electrosurgical unit.

Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.

XERF EFFECTOR 60. Electrosurgical unit.

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.

• FDA enforcement recordOfficial FDA database entry for Z-0146-2026
• FDA 510(k) clearance · K251327The device's official FDA premarket clearance record
• FDA device classification · GEIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4400The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Lutronic CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.