HIGH

Lutronic Recalls Electrosurgical Unit Due to Defect Risks

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.

Quick Facts at a Glance

Recall Date
September 4, 2025
Hazard Level
HIGH
Brand
Lutronic
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.

What You Should Do

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

Product Details

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.

The Hazard

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.

Reported Incidents

No specific incidents or injuries have been reported, but the potential for serious adverse events exists due to the defects.

What to Do

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.

Contact Information

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.

Key Facts

  • Recall date: September 4, 2025
  • Report date: October 22, 2025
  • Worldwide distribution including the US and several Asian countries
  • Quantity recalled: 7,490 units
View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeElectrosurgical Unit
Sold At
Multiple Retailers

Product Details

Model Numbers
Model/Catalog Number: 1101210000
1101210100
1101210200
UDI: 08809447657752
SERIAL/LOT: MP60J25C02
+4 more
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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