Mint Medical GmbH: Medical Device Recall in 2024 - (Recall #: Z-0709-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

mint Lesion, Software Versions: 3.9.0 through 3.9.5.

Product Classification:

Class II

Date Initiated: November 15, 2024

Date Posted: December 25, 2024

Recall Number: Z-0709-2025

Event ID: 95880

Reason for Recall:

Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.

Status: Ongoing

Product Quantity: 65 units (13 US, 52 OUS)

Code Information:

Software Versions: 3.9.0 through 3.9.5; UDI-DI: 04260495880396;

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated