Mint Lesion — Class II medical device recall Z-2068-2026
Ongoing recall by Mint Medical GmbH, reported 2026-05-13, distributed nationwide. If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing
| Recall number | Z-2068-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mint Medical GmbH, Dossenheim, Germany |
| Recall initiated | 2026-01-07 |
| Classified | 2026-05-06 |
| Reported by FDA | 2026-05-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, CZ, DE, ES, FR, GB, IE, IT, NL, PL, RO |
| Quantity | 101 systems |
| UPC / GTIN / UDI-DI | 04260495880341, 04260495880358, 04260495880365, 04260495880372, 04260495880389, 04260495880396 |
Product
Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
Reason for recall
If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be lost or incorrectly linked to other patients.
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-2068-2026. 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.