Quick Facts at a Glance
- Recall Date
- September 4, 2025
- Hazard Level
- HIGH
- Brand
- Lutronic
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Lutronic
- Product type
- Electrosurgical unit
- Model numbers
- 1101210000, 1101210100, 1101210200
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 4, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Lutronic Corporation or your healthcare provider for instructions. Notification method: Letter
About This Product
The XERF EFFECTOR 60 is an electrosurgical unit used in surgical procedures to cut and coagulate tissue. It is distributed worldwide to healthcare facilities and clinics.
Why This Is Dangerous
Manufacturing defects in devices produced during the specified window may generate unsafe operating conditions during clinical use, potentially causing adverse patient events.
Industry Context
This recall is not described as part of a broader industry pattern in the data provided.
Real-World Impact
Immediate cessation of use is required. Healthcare facilities will need to isolate affected units and coordinate with Lutronic for instructions and potential remediation.
Practical Guidance
How to identify if yours is affected
- Check Serial/Lot numbers for MP60J25C02, MP60J25G05, MP60J25G06, MP60J25H03, MP60J25H01
- Note manufacture dates 2025-04-01 to 2025-08-20
Where to find product info
Device label, packaging, or accompanying documentation for model and serial/Lot numbers; UID on instrument plate.
What timeline to expect
Refund or replacement timeline to be provided by Lutronic in recall materials.
If the manufacturer is unresponsive
- Escalate with healthcare institution risk management
- Contact FDA recall headquarters for guidance
- Document all communications with manufacturer
How to prevent similar issues
- Verify model and serial numbers before purchase
- Register devices with manufacturer for recall notifications
- Keep recall contact information handy for clinics
Documentation advice
Capture photos of the device label, serial/Lot, UDI, and dates. Save all recall notices and correspondence with Lutronic.
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Product Details
Model/Catalog Numbers: 1101210000, 1101210100, 1101210200. UDI: 08809447657752. Serial/Lot: MP60J25C02, MP60J25G05, MP60J25G06, MP60J25H03, MP60J25H01. Manufacture window: 04/01/25 to 08/20/25. Sold worldwide; US distribution includes CA, IL, MA, NJ, NY, PA, TX, UT. Quantity: 7,490 units.
Reported Incidents
No specific injuries or incidents are detailed in the provided data.
Key Facts
- 7,490 units recalled worldwide
- Manufacture window: 2025-04-01 to 2025-08-20
- Serial/Lot examples: MP60J25C02, MP60J25G05, MP60J25G06, MP60J25H03, MP60J25H01
- States listed for US distribution: CA, IL, MA, NJ, NY, PA, TX, UT
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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