HIGH

LEASEIR Surgical Laser Recalled Over Missing Danger Label

LEASEIR recalled two MHR Xcell surgical laser devices on December 15, 2025. The console label for affected devices lacks a "DANGER" symbol, posing a high hazard risk. Healthcare providers and patients must stop using the device immediately and follow recall instructions.

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

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

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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

  1. Check the serial number of your device against the affected models: C10016 and C10017.
  2. Look for the console label to verify the presence of the "DANGER" symbol.
  3. 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.

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

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
BURN

Product Details

Model Numbers
Lot Code: Device#1: Model: Leaseir MHR Xcell Serial Number: C10016
C10017 UDI-DI: 08437019546076
Affected States
ALL
Report Date
January 28, 2026
Recall Status
ACTIVE

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