CLASS II ONGOING Device recall · Reported 25 Dec 2024 · 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 15 Nov 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware Versions: 3.10.0 and 3.10.1; UDI-DI: 04260495883106;

Quantity recalled18 units (7 US, 11 OUS)

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-0710-2025
FDA event ID: 95880
Recalling firm: Mint Medical, Dossenheim
Classification: Class II
Status: Ongoing
Recall initiated: 15 Nov 2024
FDA classified: 19 Dec 2024
Reported: 25 Dec 2024
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Medical Software

Timeline

15 Nov 2024	Recall initiated by company
19 Dec 2024	Classified by FDA	+34 days
25 Dec 2024	Published in enforcement report	+6 days

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

Reason for recall

Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.

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: 3.10.0 and 3.10.1.

Where it was distributed

Worldwide distribution: US (nationwide): AR, CA, FL, GA, MI, MN, NY, OH, PA, TN, TX, WI; and OUS (International) to countries of: Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom.

Nationwide Arkansas California Florida Georgia Michigan Minnesota New York Ohio Pennsylvania Tennessee Texas Wisconsin

Questions about this recall

Why was it recalled?

Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.

Which lots are affected?

Software Versions: 3.10.0 and 3.10.1; UDI-DI: 04260495883106;

Where was it sold?

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.

Other products in this recall event

1 other product · FDA event 95880

This product is part of a recall event; the main page for the event is mint Lesion recalled by Mint Medical.

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

More recalls from Mint Medical

All 3

Reported	Class	Recall	Company	Reason	Where
13 May 2026Device	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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