Goyang, Korea (the Republic of)
Lutronic Corporation recalls
3 recalls recorded since 2018, most recently on 6 August 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)3
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 6 August 2026
- Reason
- Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and European Union.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3110-2026
- Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of 532 nm and 1064 nm through a fiber-optic handpiece. The system may be configured
Ongoing Class II Medical devices
- Recall started
- 27 January 2026
- Reason
- Reports of devices sparking/popping and potentially burning patients.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1558-2026
- CLARITY II Laser System; Model No. 1110200210.
Ongoing Class II Medical devices
- Recall started
- 4 September 2025
- Reason
- Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0146-2026
- XERF EFFECTOR 60. Electrosurgical unit.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.