Reported May 13, 2026 · Ongoing

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

Mint Medical GmbH

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mint Medical GmbH · Friedrich-Ebert-Str. 2 · Dossenheim · N/A

Is this the product you have?

  • Mint Lesion
  • Software Versions3.4.0 up to 3.9.5
Lot codes and dates
  • Software Versions3.4.0 up to 3.9.5
  • UDI-DI
    • 04260495880341
    • 04260495880358
    • 04260495880365
    • 04260495880372
    • 04260495880389
    • 04260495880396
Amount recalled
101 systems

Where it was sold

  • Nationwide

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:42 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.