FDA Medical devices recall ·
LEASEIR Product Name: LEASEIR MHR XCELL Model recall
- Recall number
- Z-1130-2026
- Date
- (initiated December 15, 2025)
- Company / brand
- Leaseir Technologies Slu
Calle Marconi G 246, Gijon, Spain - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Completed
- Units affected
- 2
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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 and destroying them without unnecessary damage to surrounding tissue. This is achieved by controlled emission of laser radiation to the target tissue. The system consists of a main console and two interchangeable applicators that delivers pulsed light in the range of 800-820nm with a peak in the 810nm in different spot sizes. Two of the applicators emitting radiation at 810 nm wavelength for two areas 13.5¿15 mm¿ and 14.5¿25.5 mm¿. Two different operation modes are available: static mode and dynamic mode, which are differentiated basically by the frequency range defined for each mode (1-4 Hz for static and 10 Hz for dynamic). The principle of operation consists in the photons travel along the axis and reflected again back into the crystal, continuing the chain reaction, while photons travelling in different directions leave the crystal. In one of the two mirrors, a tiny hole allows a small amount of light to leak out and the resulting beam is focused with lenses and is emitted from the laser. The total energy emitted by the Leaseir MHR Xcell is produced by an array of diodes. The laser emission is activated by the hand piece trigger, deliver a continuous pulse pattern while the button is pressed. Component: NO
Why was it recalled?
The console label for affected devices is missing the "DANGER" symbol.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: Device#1: Model: Leaseir MHR Xcell Serial Number: C10016, C10017 UDI-DI: 08437019546076
Distribution
US Nationwide distribution in the states of Austin, Texas.
States: Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1130-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.