# FDA recall Z-2068-2026

> **Mint Medical GmbH** · Class II · device recall initiated 2026-01-07.

## Product

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

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-2068-2026
- **Recalling firm:** Mint Medical GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-01-07
- **Report date:** 2026-05-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dossenheim, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2068-2026

## Citation

> AI Analytics. FDA recall Z-2068-2026. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-2068-2026. Source: US FDA. Licensed CC0.

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