Gijon, Spain
LEASEIR TECHNOLOGIES SLU recalls
1 recall recorded since 2018, most recently on 15 December 2025. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Completed Class II Medical devices
- Recall started
- 15 December 2025
- Reason
- The console label for affected devices is missing the "DANGER" symbol.
- Distribution
- US Nationwide distribution in the states of Austin, Texas.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1130-2026
- 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 s
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.