FDAFDA · Food and drugs·Recall number Z-2068-2026
Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
Published May 13, 2026 · Recall initiated: January 7, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Mint Medical GmbH
- Distributor
- Worldwide distribution - US Nationwide and the countries of Germany, Switzerland, Austria, Belgium, Italy, France, Romania, Netherlands, United Kingdom, Spain, Czech Republic, Ireland, Poland;
- Lot
- Software Versions: 3.4.0 up to 3.9.5. UDI-DI: 04260495880341, 04260495880358, 04260495880365, 04260495880372, 04260495880389, 04260495880396.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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