Lutronic Corporation: Device Recall
Recall #Z-0146-2026 · 09/04/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0146-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Lutronic Corporation
- Status
- Ongoing
- Date Initiated
- 09/04/2025
- Location
- Goyang, Korea (the Republic of)
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,490 units
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.
Product Description
XERF EFFECTOR 60. Electrosurgical unit.
Distribution Pattern
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.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.