Lutronic recalled 7,490 units of the XERF EFFECTOR 60 electrosurgical unit on September 4, 2025. Manufacturing defects may lead to adverse events for patients. Devices manufactured between April 1, 2025, and August 20, 2025, are affected.
Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Lutronic Corporation or your healthcare provider for instructions. Notification method: Letter
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Affected models include 1101210000, 1101210100, and 1101210200. The devices were distributed worldwide, including California, Illinois, Massachusetts, New Jersey, New York, Pennsylvania, Texas, and Utah. Pricing information is not available.
Manufacturing defects in the affected devices can result in adverse events during medical procedures. The risk level for this recall has been classified as high.
No specific incidents or injuries have been reported, but the potential for serious adverse events exists due to the defects.
Stop using the electrosurgical unit immediately. Follow the recall instructions provided by the manufacturer and contact Lutronic Corporation or your healthcare provider for further instructions.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0146-2026. Patients can also contact their healthcare provider.
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