XERF EFFECTOR 60. Electrosurgical unit.
FDA device recall Z-0146-2026 · posted 2025-10-14 · Open, Classified
Recall details
- Recalling firm
- Lutronic Corporation
- 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.
- 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.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- GEI
- Quantity affected
- 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, an
- Date initiated
- 2025-09-04
- Date posted
- 2025-10-14
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XERF (K251327) | Lutronic Corporation | 2025-08-11 |