XERF recallZ-0146-2026 · Lutronic Corporation · initiated Sep 4, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Lutronic Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.
FDA root cause category: Process change control
What the company is doing
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].
Recall details
- Recall number
- Z-0146-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 4, 2025
- Posted by the FDA
- Oct 14, 2025
- Recalling firm
- Lutronic Corporation
- Quantity
- 7,490 units
- Product code
- GEI
- FDA submissions
- K251327
- 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 description
XERF EFFECTOR 60. Electrosurgical unit.
Code information (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- XERF XERF EFFECTOR 60(900)Lutronic Corporation · Electrosurgical, Cutting & Coagulation & Accessories1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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