Product Name: DermaV Laser System Model/Catalog Number: DermaV… — Class II medical device recall Z-3110-2026
Ongoing recall by Lutronic Corporation, reported 2026-09-16, distributed nationwide. Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud nois
| Recall number | Z-3110-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lutronic Corporation, Goyang, Korea (the Republic of) |
| Recall initiated | 2026-08-06 |
| Classified | 2026-09-04 |
| Reported by FDA | 2026-09-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,065 |
| UPC / GTIN / UDI-DI | 08800291820200 |
| Serial numbers | DV025A010, DV025A011, DV025A012, DV025A013, DV025A014, DV025A015, DV025A016, DV025A018, DV025A019, DV025A020, DV025A021, DV025A022, DV025B011, DV025B012, DV025B013, DV025B014, DV025B015, DV025D006, DV025D007, DV025D008, DV025D009, DV025D010, DV025E003, DV025E004, DV025E005 and 68 more |
Product
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 with an Intelligent Cooling Device (ICD) to provide epidermal cooling during laser treatment
Reason for recall
Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3110-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.