FDA DevicesClass II
Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
Published: May 13, 2026Recall ID: Z-2068-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
Affected Products
Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
Additional Source Details
| Field | Value |
|---|---|
| City | Dossenheim |
| Event id | 98753 |
| Address 1 | Friedrich-Ebert-Str. 2 |
| Code info | Software Versions: 3.4.0 up to 3.9.5. UDI-DI: 04260495880341, 04260495880358, 04260495880365, 04260495880372, 04260495880389, 04260495880396. |
| Postal code | N/A |
| Report date | 20260513 |
| Product type | Devices |
| Product quantity | 101 systems |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260107 |
| Initial firm notification | |
| Center classification date | 20260506 |
Overview
- Recalling FirmMint Medical GmbH
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of Germany, Switzerland, Austria, Belgium, Italy, France, Romania, Netherlands, United Kingdom, Spain, Czech Republic, Ireland, Poland;