Dossenheim, Germany
Mint Medical GmbH recalls
2 recalls recorded since 2018, most recently on 7 January 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 7 January 2026
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Germany, Switzerland, Austria, Belgium, Italy, France, Romania, Netherlands, United Kingdom, Spain, Czech Republic, Ireland, Poland;
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2068-2026
- Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
Ongoing Class II Medical devices
- Recall started
- 15 November 2024
- Reason
- Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
- Distribution
- Worldwide distribution: US (nationwide): AR, CA, FL, GA, MI, MN, NY, OH, PA, TN, TX, WI; and OUS (International) to countries of: Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0709-2025, Z-0710-2025
- mint Lesion, Software Versions: 3.9.0 through 3.9.5.
- mint Lesion, Software Versions: 3.10.0 and 3.10.1.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.