Recall Z-1130-2026 ยท GEX Powered Laser Surgical Instrument
LEASEIR TECHNOLOGIES SLU
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
| Date | Jan 16, 2026 (initiated Dec 15, 2025) |
| Status | Completed |
| Reason | The console label for affected devices is missing the "DANGER" symbol. |
| 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 | 2 |
| Distribution | US Nationwide distribution in the states of Austin, Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K214049 | Leaseir MHR Xcell Leaseir Technologies, Slu, Jun 2, 2022 |