Z-0146-2026Class II

XERF EFFECTOR 60. Electrosurgical unit

Name: Z-0146-2026 XERF EFFECTOR 60. Electrosurgical unit
Creator: Lutronic Corporation
Published: 2025-09-04
License: https://open.fda.gov/license/

Lutronic Corporation / initiated 2025-09-04 / Open, Classified / root cause: manufacturing process

FDA source

Lutronic Corporation began a recall of XERF EFFECTOR 60. Electrosurgical unit on 2025-09-04. FDA classified it as Class II and gives the reason as "Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0146-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-04
Posted: 2025-10-14
Recalling firm: Lutronic Corporation
Product: XERF EFFECTOR 60. Electrosurgical unit.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: manufacturing process
FDA root cause: Process change control
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].
Quantity in commerce: 7,490 units
Distribution: 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.
Product codes and lots: Model/Catalog Number: 1101210000, 1101210100, 1101210200; UDI: 08809447657752, SERIAL/LOT: MP60J25C02, MP60J25G05, MP60J25G06, MP60J25H03, and MP60J25H01. Devices manufactured from 04/01/25 to 08/20/25.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0146-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0146-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-14

Product code GEI

K251327Class IIXerfLutronic Corporation / cleared 2025-08-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)