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

Recall date

January 7, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2068-2026

FDA classification

Class II

Brand / firm

Mint Medical GmbH

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Germany, Switzerland, Austria, Belgium, Italy, France, Romania, Netherlands, United Kingdom, Spain, Czech Republic, Ireland, Poland;

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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