Recall
FDAHealthJanuary 7, 2026

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.;
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.

View original FDA notice →

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