Z-0146-2026 Class II Ongoing
FDA device recall Z-0146-2026 was initiated by Lutronic Corporation on September 4, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 7,490 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 22, 2025
- Initiation Date
- September 4, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,490 units
Product Description
XERF EFFECTOR 60. Electrosurgical unit.
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.
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.
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.