Recall Z-0146-2026— Lutronic Corporation

Name: FDA recall Z-0146-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-04

Class II · Ongoing

Class II FDA medical device recall by Lutronic Corporation, initiated 2025-09-04. It names one FDA 510(k) clearance: K251327. Product: XERF EFFECTOR 60. Electrosurgical unit.. Reason: Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients..

Recalling firm: Lutronic Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-09-04
Firm location: Goyang, Korea (the Republic of)

510(k) clearances named in this recall

1 on FDA's record

K251327 — XERFLutronic Corporation·cleared 2025-08-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

XERF EFFECTOR 60. Electrosurgical unit.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.