Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product De
FDA device recall Z-1130-2026 · posted 2026-01-16 · Completed
Recall details
- Recalling firm
- LEASEIR TECHNOLOGIES SLU
- Reason for recall
- The console label for affected devices is missing the "DANGER" symbol.
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Completed
- Product code
- GEX
- Quantity affected
- 2
- Distribution
- US Nationwide distribution in the states of Austin, Texas.
- Date initiated
- 2025-12-15
- Date posted
- 2026-01-16
- Location
- Gijon, Spain
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Leaseir MHR Xcell (K214049) | Leaseir Technologies, Slu | 2022-06-02 |