Lutronic recalls XERF EFFECTOR 60 electrosurgical units made between April 2025 and August 2025 due to rare patient adverse events from manufacturing defects.
“Lutronic XERF EFFECTOR 60 Electrosurgical Unit Recall: Rare Patient Adverse Events.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51452-lutronic-xerf-effector-60-electrosurgical-unit-recall-rare-patient-adverse. Based on FDA recall #Z-0146-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0146-2026%22&limit=1).
The FDA announced on Sept. 4, 2025, that Lutronic Corporation is recalling the XERF EFFECTOR 60 electrosurgical unit due to manufacturing defects that can result in adverse patient events. The recall affects devices manufactured between April 1 and Aug. 20, 2025.
According to the FDA, manufacturing defects in devices produced from April 1, 2025, to Aug. 20, 2025, can on rare occasions result in adverse events for patients.
Context
GovInfoNow's records show Lutronic Corporation has two other recalls on record since Jan. 27, 2026. On Aug. 6, 2026, the company recalled the DermaV Laser System due to a risk of patient burn during treatment. On Jan. 27, 2026, the CLARITY II Laser System was recalled for sparking and potential patient burns. Other recent recalls of similar products include Philips Allura Xper FD10C Medical System Recall (Dec. 15, 2025), Philips Allura Xper FD10F Medical System Recall (Dec. 15, 2025), and Bard PowerPICC Catheters Recall (May 21, 2026).
How to tell if you have this one
Check for model numbers 1101210000, 1101210100, or 1101210200. Devices manufactured from April 1, 2025 to August 20, 2025 are affected.
Brand
Lutronic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Verify the model number and production date against the listed identifiers to confirm if the device is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 8 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Illinois, Massachusetts, New Jersey, New York, Pennsylvania, Texas, Utah.
Recall timeline
FDA published this recall 48 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0146-2026 (September 4, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0146-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.