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 | 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. |
| Product | Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.; |
| Quantity | 101 systems |
| Distribution | Worldwide distribution - US Nationwide and the countries of Germany, Switzerland, Austria, Belgium, Italy, France, Romania, Netherlands, United Kingdom, Spain, Czech Republic, Ireland, Poland; |
| Initiated | 2026-01-07 |
| Classified | 2026-05-06 |
| Recall number | Z-2068-2026 |
| 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-2068-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98753/
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