Class II — Mint Medical GmbH
| Recalling firm | Mint Medical GmbH |
|---|---|
| Registered facility | MINT MEDICAL GMBH (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images. |
| Product | mint Lesion, Software Versions: 3.10.0 and 3.10.1. |
| Quantity | 18 units (7 US, 11 OUS) |
| Distribution | Worldwide distribution: US (nationwide): AR, CA, FL, GA, MI, MN, NY, OH, PA, TN, TX, WI; and OUS (International) to countries of: Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom. |
| Initiated | 2024-11-15 |
| Classified | 2024-12-19 |
| Recall number | Z-0710-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Mint Medical GmbH (Z-0710-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95880/
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