Z-1130-2026Class II

Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0...

Name: Z-1130-2026 Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0...
Creator: Leaseir Technologies Slu
Published: 2025-12-15
License: https://open.fda.gov/license/

Leaseir Technologies SLU / initiated 2025-12-15 / Completed / root cause: labeling and UDI

FDA source

LEASEIR TECHNOLOGIES SLU began a recall of 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... on 2025-12-15. FDA classified it as Class II and gives the reason as "The console label for affected devices is missing the "DANGER" symbol". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1130-2026
Classification: Class II
Status: Completed
Initiated: 2025-12-15
Posted: 2026-01-16
Recalling firm: Leaseir Technologies SLU
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 13.515 mm and 14.525.5 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
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: The console label for affected devices is missing the "DANGER" symbol.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On October 29, 2025, the firm notified the single US consignee. This was followed up by an email on December 18, 2025. The consignee was given information regarding the field corrective action for the console labels and missing danger symbol. The consignee was provided with replacement labels and instructions for the correction of both affected units.
Quantity in commerce: 2
Distribution: US Nationwide distribution in the states of Austin, Texas.
Product codes and lots: Lot Code: Device#1: Model: Leaseir MHR Xcell Serial Number: C10016, C10017 UDI-DI: 08437019546076

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1130-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1130-2026	Class II	Completed	Voluntary: Firm initiated	2026-01-28	2026-01-16

Product code GEX

K214049Class IILeaseir MHR XcellLeaseir Technologies, Slu / cleared 2022-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)