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Mint Lesion recallZ-2068-2026 · Mint Medical GmbH · initiated Jan 7, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Mint Medical GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

On or about January 7, 2026 Urgent Field Safety Notice letters were emailed to customers. Customers were instructed to read the notice and check if any affected product is available for use. If that is the case, the malfunction may have occurred and may occur in your system. Please be aware that the malfunction may occur. Your IT department must ensure that no temporary network interruptions occur in your clinical network. Also, your IT department must ensure that the mint Lesion server is not restarted while users work with mint Lesion application (i.e., the server may be restartet, but only outside of working hours). Please verify correctness of the information of prior time-points. Be attentive to potential inconsistencies in lesion attributes when opening existing cases for follow up. Cross check lesion location and categorization with prior radiological reports and image data. If you suspect that the problem may have occurred on your mint Lesion system, please contact Mint Medical support via [email protected] or any other contact details for technical analysis and investigation. Mint Medical Support will analyze if the malfunction appeared at your mint Lesion system in the past. If you believe that this failure has occurred, please review the potentially affected radiological reports in your reporting application and take the necessary steps to correct them. Pass this notice on to all users of mint Lesion" within your organization. Please maintain awareness of this notice and resulting action for an appropriate period to ensure the effectiveness of the corrective action.

Recall details

Recall number
Z-2068-2026
Status
Open, Classified
Initiated by the company
Jan 7, 2026
Posted by the FDA
May 6, 2026
Recalling firm
Mint Medical GmbH
Quantity
101 systems
Product code
LLZ
FDA submissions
K142647
Distribution
Worldwide distribution - US Nationwide and the countries of Germany, Switzerland, Austria, Belgium, Italy, France, Romania, Netherlands, United Kingdom, Spain, Czech Republic, Ireland, Poland;

Product description

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

Code information (models, lots, serial numbers)

Software Versions: 3.4.0 up to 3.9.5. UDI-DI: 04260495880341, 04260495880358, 04260495880365, 04260495880372, 04260495880389, 04260495880396.

Devices named in this recall

6 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

1 device cleared under K142647 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page