CLASS II ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report
Xerf Effector Electrosurgical unit recalled by Lutronic
Lutronic is recalling Xerf Effector Electrosurgical unit, distributed nationwide in the US. The recall was initiated on 4 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0146-2026
- FDA event ID
- 97620
- Recalling firm
- Lutronic, Goyang
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Sep 2025
- FDA classified
- 14 Oct 2025
- Reported
- 22 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 4 Sep 2025 | Recall initiated by company | |
| 14 Oct 2025 | Classified by FDA | +40 days |
| 22 Oct 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
XERF EFFECTOR 60. Electrosurgical unit.
Where it was distributed
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.
Nationwide CaliforniaIllinoisMassachusettsNew JerseyNew YorkPennsylvaniaTexasUtah
Questions about this recall
Is Xerf Effector Electrosurgical unit recalled?
Yes. Lutronic recalled Xerf Effector Electrosurgical unit on 4 Sep 2025. The recall is Class II and its status is Ongoing. Recall number Z-0146-2026.
Why was it recalled?
Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.
Which lots are affected?
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.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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