FDA Medical devices recall ·
XERF EFFECTOR 60. Electrosurgical unit recall
- Recall number
- Z-0146-2026
- Date
- (initiated September 4, 2025)
- Company / brand
- Lutronic Corporation
219 Sowon-Ro; Deogyang, Goyang, Korea (the Republic of) - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 7,490 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
XERF EFFECTOR 60. Electrosurgical unit.
Why was it recalled?
Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
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.
States: California Illinois Massachusetts New Jersey New York Pennsylvania Texas Utah
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0146-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.