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U.S. Department of Health and Human Services

Class 2 Device Recall Mint Lesion

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 Class 2 Device Recall Mint Lesionsee related information
Date Initiated by FirmJanuary 07, 2026
Date PostedMay 06, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2068-2026
Recall Event ID 98753
510(K)NumberK142647 
Product Classification System, image processing, radiological - Product Code LLZ
ProductMint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
Code Information Software Versions: 3.4.0 up to 3.9.5. UDI-DI: 04260495880341, 04260495880358, 04260495880365, 04260495880372, 04260495880389, 04260495880396.
FEI Number 3011706018
Recalling Firm/
Manufacturer		 Mint Medical GmbH
Friedrich-Ebert-Str. 2
Dossenheim Germany
Manufacturer Reason
for Recall		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 Determined
Cause 2		Under Investigation by firm
ActionOn 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 support@mint-medical.com 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.
Quantity in Commerce101 systems
DistributionWorldwide distribution - US Nationwide and the countries of Germany, Switzerland, Austria, Belgium, Italy, France, Romania, Netherlands, United Kingdom, Spain, Czech Republic, Ireland, Poland;
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LLZ
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