FDA recall, , Moderate risk
Leaseir MHR Xcell Surgical Laser Instruments
The Leaseir MHR Xcell surgical laser instrument is missing the Danger symbol on its console label.
Summary by Recall Canary from the FDA notice
What happened
LEASEIR TECHNOLOGIES SLU, based in Gijon, Spain, recalled the Leaseir MHR Xcell surgical laser instrument, model MHR 110-b with software version 1.5.0.0, because the console label for affected devices is missing the DANGER symbol. The device is used in general and plastic surgery and dermatology for hair removal and treatment of pseudo folliculitis barbae on all skin types (Fitzpatrick I-VI).
The recall began December 15, 2025, and was added to the FDA's Enforcement Report on January 16, 2026. The device was distributed nationwide in the United States, including Austin, Texas.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
Leaseir MHR Xcell
- Model number
- MHR 110-b
From the FDA notice
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).
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Austin, Texas.
- Company
- LEASEIR TECHNOLOGIES SLUGijon, Spain
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98176
- Recall number
- Z-1130-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
