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Open, Classified

XERF EFFECTOR 60. Electrosurgical unit.

FDA Recall Z-0146-2026 · Posted 2025-10-14

Recalling FirmLutronic Corporation
Recall StatusOpen, Classified
Product CodeGEI
Date Initiated2025-09-04
Product Quantity7,490 units

Reason for Recall

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

Firm Action

An URGENT-Field Safety Corrective Action - XERF Tips notification dated 9/4/25 was mailed to consignees notifying them of this recall. Consignees are instructed to immediately stop use of affected devices and to return all units utilizing the provided shipping label. Consignees with any questions can contact Customer Service at 1-800-886-2966 or by email at [email protected].

Root Cause

Process change control

Distribution Pattern

Worldwide - US Nationwide distribution in the states of CA, IL, MA, NJ, NY, PA, TX, and UT. The countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K251327XERFLutronic Corporation · 2025-08-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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