Mint Lesion recall (Mint Medical GmbH)
Medical deviceClass IIOngoing
Summary: Mint Medical GmbH is recalling 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.
What is being recalled
Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Germany, Switzerland, Austria, Belgium, Italy, France, Romania, Netherlands, United Kingdom, Spain, Czech Republic, Ireland, Poland;
How to tell if yours is affected
Software Versions: 3.4.0 up to 3.9.5. UDI-DI: 04260495880341, 04260495880358, 04260495880365, 04260495880372, 04260495880389, 04260495880396.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2068-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | January 7, 2026 |
| Reported | May 13, 2026 |
| Company | Mint Medical GmbH |
| Company location | Dossenheim, Germany |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 101 systems |
More recalls from Mint Medical GmbH · all medical device recalls · recalls from January 2026