Z-2068-2026Class II

Mint Lesion; Software Versions: 3.4.0 up to 3.9.5

Name: Z-2068-2026 Mint Lesion; Software Versions: 3.4.0 up to 3.9.5
Creator: Mint Medical GmbH
Published: 2026-01-07
License: https://open.fda.gov/license/

Mint Medical GmbH / initiated 2026-01-07 / Open, Classified

FDA source

Mint Medical GmbH began a recall of Mint Lesion; Software Versions: 3.4.0 up to 3.9.5 on 2026-01-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2068-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-07
Posted: 2026-05-06
Recalling firm: Mint Medical GmbH
Product: Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
Product code: LLZ System, Image Processing, Radiological
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 root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 101 systems
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 codes and lots: Software Versions: 3.4.0 up to 3.9.5. UDI-DI: 04260495880341, 04260495880358, 04260495880365, 04260495880372, 04260495880389, 04260495880396.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2068-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2068-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-06

Product code LLZ

K142647Class IImint LesionMint Medical GmbH / cleared 2015-04-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)