Mint Medical GmbH — Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 7, 2026
Worldwide distribution - US Nationwide and the countries of Germany, Switzerland, Austria, Belgium, Italy, France, Romania, Netherlands, United Kingdom, Spain, Czech Republic, Ireland, Poland;
What's affected?
- Product
- Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
- Brand
- Mint Medical GmbH
- Lot code
- Software Versions: 3.4.0 up to 3.9.5. UDI-DI: 04260495880341, 04260495880358, 04260495880365, 04260495880372, 04260495880389, 04260495880396.
Additional details
Software Versions: 3.4.0 up to 3.9.5. UDI-DI: 04260495880341, 04260495880358, 04260495880365, 04260495880372, 04260495880389, 04260495880396.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 101 systems.
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