Z-2068-2026Class II

Mint Medical GmbH

Recalling firm

Mint Medical GmbH

Product type

Device

Status

Ongoing

Report date

2026-05-13

Distribution

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

Product quantity

101 systems

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Documentation & Change Control

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.

Product description

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

Code / lot info

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

Other recalls SPEQ maps to Documentation & Change Control

2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class IIFayus Inc.2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class ID'Dioses Fruit Pops, Inc.

See all Documentation & Change Control recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.