Lutronic recalls

3 official recalls and safety alerts involving Lutronic since 2025-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Lutronic or the relevant agency.

  1. 2026-09-16
  2. US
    Drugs & medicalClass II

    Lutronic Corporation recalls Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of…

    Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.

    FDA · DeviceLutronic CorporationWorldwide distribution - US Nationwide and the countries of Canada and…Official notice →
  3. 2026-03-18
  4. US
    Drugs & medicalClass II

    Lutronic Corporation recalls CLARITY II Laser System; Model No. 1110200210.

    Reports of devices sparking/popping and potentially burning patients.

    FDA · DeviceLutronic CorporationWorldwide distribution - US Nationwide and the countries of Canada, South…Official notice →
  5. 2025-10-22
  6. US
    Drugs & medicalClass II

    Lutronic Corporation recalls XERF EFFECTOR 60. Electrosurgical unit.

    Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.

    FDA · DeviceLutronic CorporationWorldwide - US Nationwide distribution in the states of CA, IL, MA, NJ, NY,…Official notice →