CLASS II ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report

Mint Lesion recalled by Mint Medical

Mint Medical is recalling Mint Lesion, distributed nationwide in the US. The recall was initiated on 7 Jan 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware Versions: 3.4.0 up to 3.9.5. UDI-DI: 04260495880341, 04260495880358, 04260495880365, 04260495880372, 04260495880389, 04260495880396.

Quantity recalled101 systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2068-2026
FDA event ID: 98753
Recalling firm: Mint Medical, Dossenheim
Classification: Class II
Status: Ongoing
Recall initiated: 7 Jan 2026
FDA classified: 6 May 2026
Reported: 13 May 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Medical Software

Timeline

7 Jan 2026	Recall initiated by company
6 May 2026	Classified by FDA	+119 days
13 May 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Germany, Switzerland, Austria, Belgium, Italy, France, Romania, Netherlands, United Kingdom, Spain, Czech Republic, Ireland, Poland;

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Germany, Switzerland, Austria, Belgium, Italy, France, Romania, Netherlands, United Kingdom, Spain, Czech Republic, Ireland, Poland;

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Mint Medical

All 3

Reported	Class	Recall	Company	Reason	Where
25 Dec 2024Device	CLASS II	mint Lesion recalled by Mint Medical	Mint Medical	Device Malfunction	Nationwide
25 Dec 2024Device	CLASS II	mint Lesion recalled by Mint Medical	Mint Medical	Device Malfunction	Nationwide

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