Summary
The FDA issued a Class II for Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.; by Mint Medical GmbH. 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.
Details
Source
Device Recall
External ID
Z-2068-2026
Action Date
2026-05-13
Status
Ongoing
Category
device
Product Description
Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
Lot/Code Info: Software Versions: 3.4.0 up to 3.9.5. UDI-DI: 04260495880341, 04260495880358, 04260495880365, 04260495880372, 04260495880389, 04260495880396.
Quantity Affected: 101 systems
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Germany, Switzerland, Austria, Belgium, Italy, France, Romania, Netherlands, United Kingdom, Spain, Czech Republic, Ireland, Poland;
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-07
Company
Dossenheim
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 250 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Mint Medical GmbH has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mint Medical GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mint Medical GmbH have FDA actions?
Mint Medical GmbH has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2068-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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