Electrosurgical unit recalled nationwide due to manufacturing defects
Lutronic Corporation is recalling 7,490 XERF EFFECTOR 60 electrosurgical units manufactured from April through August 2025 due to manufacturing defects that can result in adverse patient events. The recall includes units distributed in the US and multiple international locations.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The affected device is FDA Class II with manufacturing defects that pose a risk of harm to patients. However, no illnesses, injuries, or deaths have been reported. Per the severity rubric, risk-of-harm products without reported incidents score 3 (High).
Plain-English summary
Lutronic Corporation is recalling the XERF EFFECTOR 60 electrosurgical unit, an FDA Class II medical device. The recall affects 7,490 units manufactured between April 1, 2025 and August 20, 2025. Affected devices include Model numbers 1101210000, 1101210100, and 1101210200, with specific lot numbers MP60J25C02, MP60J25G05, MP60J25G06, MP60J25H03, and MP60J25H01.
The affected units have been distributed nationwide in eight US states (California, Illinois, Massachusetts, New Jersey, New York, Pennsylvania, Texas, and Utah) as well as internationally in Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.
Manufacturing defects in the affected devices can on rare occasions result in adverse events for patients. No illnesses, injuries, or deaths have been reported.
Healthcare providers and facilities using the XERF EFFECTOR 60 should stop using affected units and contact Lutronic Corporation for remedy instructions.
The recalled product
- Product
- XERF EFFECTOR 60. Electrosurgical unit.
- Manufacturer
- Lutronic Corporation
- Hazard
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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
Distributed nationwide across the United States.
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