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CLASS II · ModerateFDA

Mint Medical GmbH recalls Mint Lesion

📅 Jan 7, 2026 · 📍 Nationwide
Recalling company
Mint Medical GmbH
Product
Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Jan 7, 2026
Reported
May 13, 2026
Distribution
Worldwide distribution - US Nationwide and the countries of Germany, Switzerland, Austria, Belgium, Italy, France, Romania, Netherlands, United Kingdom, Spain, Czech Republic, Ireland, Poland;
Status
Ongoing
Quantity
101 systems
Lot / codes
Software Versions: 3.4.0 up to 3.9.5. UDI-DI: 04260495880341, 04260495880358, 04260495880365, 04260495880372, 04260495880389, 04260495880396.
Company location
Dossenheim
Recall type
Voluntary: Firm initiated
Recall number
Z-2068-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2068-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.