FDA recall, , Moderate risk
Mint Lesion
If the connection between a Mint Lesion workstation and the server is interrupted while performing a read, some information may be lost or incorrectly linked to other patients.
Summary by Recall Canary from the FDA notice
What happened
Mint Medical GmbH, based in Dossenheim, Germany, began a recall of its Mint Lesion software, versions 3.4.0 up to 3.9.5, on January 7, 2026. The FDA added the recall to its Enforcement Report and classified it on May 6, 2026, and included it in the weekly enforcement report on May 13, 2026.
The recall covers 101 systems distributed worldwide, including the US Nationwide and Germany, Switzerland, Austria, Belgium, Italy, France, Romania, Netherlands, United Kingdom, Spain, Czech Republic, Ireland, and Poland.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
- UDI-DI
- 04260495880341
- 04260495880358
- 04260495880365
- 04260495880372
- 04260495880389
- 04260495880396
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Germany, Switzerland, Austria, Belgium, Italy, France, Romania, Netherlands, United Kingdom, Spain, Czech Republic, Ireland, Poland;
- Company
- Mint Medical GmbHDossenheim, Germany
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98753
- Recall number
- Z-2068-2026
- Quantity recalled
- 101 systems
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
