FDA Medical devices recall ·
Mint Lesion recall
- Recall number
- Z-2068-2026
- Date
- (initiated January 7, 2026)
- Company / brand
- Mint Medical GmbH
Friedrich-Ebert-Str. 2, Dossenheim, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 101 systems
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Software Versions: 3.4.0 up to 3.9.5. UDI-DI: 04260495880341, 04260495880358, 04260495880365, 04260495880372, 04260495880389, 04260495880396.
Distribution
Worldwide distribution - US Nationwide and the countries of Germany, Switzerland, Austria, Belgium, Italy, France, Romania, Netherlands, United Kingdom, Spain, Czech Republic, Ireland, Poland;
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2068-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.