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MEDICAL DEVICE RECALLMODERATE

Mint Lesion Software

Mint Medical is recalling Mint Lesion software versions 3.4.0–3.9.5 due to a risk of data loss or incorrect patient information linking.

What to do

Contact your local Mint Medical representative or technical support team for guidance on software updates and to ensure data integrity within your clinical workflow.

Recalled
Listed
Updated
Recall No.
Z-2068-2026
Agency
FDA
Firm
Mint Medical GmbH
Recall ID
98753
Status
ONGOING

Recall at a glance

Quantity recalled
101 systems

Why it was recalled

Mint Medical is recalling Mint Lesion software versions 3.4.0 through 3.9.5 due to a risk of data loss or incorrect patient information linking if the connection between the workstation and server is interrupted during a read. This issue could lead to inaccurate diagnostic information being presented to clinicians.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

UDI-DI
04260495880341, 04260495880358, 04260495880365, 04260495880372, 04260495880389, 04260495880396

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification