Electrosurgical units recalled over manufacturing defects that may cause adverse events
Lutronic is recalling 7,490 XERF EFFECTOR 60 electrosurgical units because manufacturing defects in devices made between April and August 2025 can on rare occasions result in adverse events.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: the firm states the defect can result in patient adverse events, and the record gives no injury count.
Plain-English summary
The XERF EFFECTOR 60 electrosurgical unit is being recalled, covering model/catalog numbers 1101210000, 1101210100 and 1101210200.
Manufacturing defects in devices manufactured from 1 April 2025 to 20 August 2025 can on rare occasions result in adverse events for patients.
The recall covers 7,490 units carrying UDI 08809447657752. Distribution was worldwide, including in California, Illinois, Massachusetts, New Jersey, New York, Pennsylvania, Texas and Utah. The FDA has classified the action as Class II.
The enforcement record does not specify the nature of the adverse events or report a count. Facilities operating affected serial numbers should follow Lutronic's instructions.
The recalled product
- Product
- XERF EFFECTOR 60. Electrosurgical unit.
- Manufacturer
- Lutronic Corporation
- Affected units
- 7,490
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
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