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.
The console label for affected devices is missing the "DANGER" symbol.
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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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.
The lack of a "DANGER" symbol on the console label poses a significant risk to users. This omission may prevent proper identification of hazards associated with the device's operation.
No injuries or deaths have been reported regarding this recall. The absence of appropriate labeling could lead to unsafe usage conditions.
Stop using the device immediately. Follow the recall instructions provided by LEASEIR TECHNOLOGIES SLU and contact your healthcare provider for further guidance.
For more information, contact LEASEIR TECHNOLOGIES SLU via email. Details can be found on the FDA's recall page.
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