Recall Z-0146-2026 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Lutronic Corporation
XERF EFFECTOR 60. Electrosurgical unit.
| Date | Oct 14, 2025 (initiated Sep 4, 2025) |
| Status | Open, Classified |
| Reason | Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients. |
| Root cause | Process change control |
| Action | 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. |
| Quantity | 7,490 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K251327 | XERF Lutronic Corporation, Aug 11, 2025 |