# FDA recall Z-1130-2026

> **LEASEIR TECHNOLOGIES SLU** · Class II · device recall initiated 2025-12-15.

## 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 a

## Reason for recall

The console label for affected devices is missing the "DANGER" symbol.

## Distribution

US Nationwide distribution in the states of Austin, Texas.

## Key facts

- **Recall number:** Z-1130-2026
- **Recalling firm:** LEASEIR TECHNOLOGIES SLU
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2025-12-15
- **Report date:** 2026-01-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gijon, Spain

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1130-2026

## Citation

> AI Analytics. FDA recall Z-1130-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1130-2026. Source: US FDA. Licensed CC0.

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