Lutronic recalled 7,490 XERF EFFECTOR 60 electrosurgical units distributed worldwide, including several U.S. states, after manufacturing defects surfaced between April 1 and August 20, 2025. The defect can cause adverse events for patients. Healthcare providers and patients should stop using the device immediately and follow the manufacturer’s recall instructions.
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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The XERF EFFECTOR 60 is an electrosurgical unit used in surgical procedures to cut and coagulate tissue. It is distributed worldwide to healthcare facilities and clinics.
Manufacturing defects in devices produced during the specified window may generate unsafe operating conditions during clinical use, potentially causing adverse patient events.
This recall is not described as part of a broader industry pattern in the data provided.
Immediate cessation of use is required. Healthcare facilities will need to isolate affected units and coordinate with Lutronic for instructions and potential remediation.
Device label, packaging, or accompanying documentation for model and serial/Lot numbers; UID on instrument plate.
Refund or replacement timeline to be provided by Lutronic in recall materials.
Capture photos of the device label, serial/Lot, UDI, and dates. Save all recall notices and correspondence with Lutronic.
Model/Catalog Numbers: 1101210000, 1101210100, 1101210200. UDI: 08809447657752. Serial/Lot: MP60J25C02, MP60J25G05, MP60J25G06, MP60J25H03, MP60J25H01. Manufacture window: 04/01/25 to 08/20/25. Sold worldwide; US distribution includes CA, IL, MA, NJ, NY, PA, TX, UT. Quantity: 7,490 units.
No specific injuries or incidents are detailed in the provided data.
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