mint Lesion — Class II medical device recall Z-0709-2025
Ongoing recall by Mint Medical GmbH, reported 2024-12-25, distributed nationwide. Some software versions have a malfunction where they may show incorrect orientation labels for a specific subs
| Recall number | Z-0709-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mint Medical GmbH, Dossenheim, Germany |
| Recall initiated | 2024-11-15 |
| Classified | 2024-12-19 |
| Reported by FDA | 2024-12-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, DE, ES, FR, GB, IT, NL |
| Reason classes | labeling, device malfunction, software |
| UPC / GTIN / UDI-DI | 04260495880396 |
Product
mint Lesion, Software Versions: 3.9.0 through 3.9.5.
Reason for recall
Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0709-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.