Quick Facts at a Glance
- Recall Date
- December 15, 2025
- Hazard Level
- HIGH
- Brand
- LEASEIR TECHNOLOGIES SLU
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- LEASEIR TECHNOLOGIES SLU
- Product type
- Surgical Laser Instrument
- Model numbers
- Lot Code: Device#1: Model: Leaseir MHR Xcell Serial Number: C10016, C10017 UDI-DI: 08437019546076
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 15, 2025
Reported by FDA DEVICE
January 28, 2026
RecallRadar source check
February 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
The console label for affected devices is missing the "DANGER" symbol.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact LEASEIR TECHNOLOGIES SLU or your healthcare provider for instructions. Notification method: E-Mail
About This Product
The LEASEIR MHR Xcell is designed for surgical applications, including hair removal and treatment for skin conditions. It is used in medical settings by professionals in dermatology and plastic surgery.
Why This Is Dangerous
The absence of the "DANGER" label could lead to unawareness of potential risks during operation, increasing the likelihood of misuse or accidents.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must stop using the device immediately, which may disrupt ongoing treatments and require alternative solutions.
Practical Guidance
How to identify if yours is affected
- Check the serial number of your device against the affected models: C10016 and C10017.
- Look for the console label to verify the presence of the "DANGER" symbol.
- Determine if your device has been used in recent procedures.
Where to find product info
Serial numbers can typically be found on the device's main console or back panel. Refer to the user manual for specifics.
What timeline to expect
Expect 4-6 weeks for processing of refunds or replacements after returning the device.
If the manufacturer is unresponsive
- Contact LEASEIR via their official email address provided in the recall notice.
- Reach out to the FDA if you do not receive a response.
How to prevent similar issues
- Always check for safety labeling on medical devices before use.
- Stay informed about recalls related to medical equipment you may use.
- Consult healthcare professionals about the safety of devices used in treatments.
Documentation advice
Maintain records of your purchase, correspondence regarding the recall, and any communications with healthcare providers.
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Product Details
The recall affects two models: Leaseir MHR Xcell, Serial Numbers C10016 and C10017, UDI-DI: 08437019546076. These devices were distributed nationwide, specifically in Austin, Texas. They are used for hair removal and treatment of pseudo folliculitis barbae.
Key Facts
- Recall date: December 15, 2025
- Models affected: Leaseir MHR Xcell, Serial Numbers C10016, C10017
- Hazard level: High
- No reported injuries or deaths
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Safety Guide
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