Class II — LEASEIR TECHNOLOGIES SLU
| Recalling firm | Leaseir Technologies SLU |
|---|---|
| Registered facility | LEASEIR TECHNOLOGIES SLU (the firm's only registered facility) |
| Classification | Class II |
| Status | Completed |
| Reason | The console label for affected devices is missing the "DANGER" symbol. |
| Product | Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: The Leaseir MHR Xcell is a surgical laser instrument for use in general and plastic surgery and dermatology, intended for hair removal and treatment of pseudo folliculitis barbae on all skin types (Fitzpatrick I-VI). The process implies the generation of intense light pulses at specific wavelengths. The specific nature of the energies and pulse durations cause the desired effect (in the hair follicles and oxyhemoglobin in the blood) heating them sufficiently a… |
| Quantity | 2 |
| Distribution | US Nationwide distribution in the states of Austin, Texas. |
| Initiated | 2025-12-15 |
| Classified | 2026-01-16 |
| Recall number | Z-1130-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — LEASEIR TECHNOLOGIES SLU (Z-1130-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98176/
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