Warning
Mint Medical GmbH Recalls Mint Lesion; Software Versions: 3.4.0 up to 3.9.5
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-2068-2026Medical Device
Mint Medical GmbH Recalls Mint Lesion; Software Versions: 3.4.0 up to 3.9.5
Mint Medical GmbH · Class II — Moderate Risk
Product Description
Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Worldwide distribution - US Nationwide and the countries of Germany, Switzerland, Austria, Belgium, Italy, France, Romania, Netherlands, United Kingdom, Spain, Czech Republic, Ireland, Poland;
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class II FDA recall has been issued for a medical device from Mint Medical GmbH, initiated on January 7, 2026. 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. This recall covers 101 systems, distributed internationally, including the United States. While not the highest severity, consumers should exercise caution and stop using the product until the recall is resolved.
Sources: FDA openFDA Enforcement Database
This recall appears in: Other Injury Hazards.