⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Mint Medical GmbH: Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;

Medical DevicesSource: FDA (device) · Date: 2026-05-13

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Mint Medical GmbH
Product
Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
Reason / hazard
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
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide and the countries of Germany, Switzerland, Austria, Belgium, Italy, France, Romania, Netherlands, United Kingdom, Spain, Czech Republic, Ireland, Poland;
Recall initiated
2026-01-07
Code info
Software Versions: 3.4.0 up to 3.9.5. UDI-DI: 04260495880341, 04260495880358, 04260495880365, 04260495880372, 04260495880389, 04260495880396.
Product quantity
101 systems
Voluntary mandated
Voluntary: Firm initiated
City
Dossenheim
Country
Germany
Event id
98753
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