{"url_path":"/fda/device/recalls/Z-2068-2026","section_key":"summary","section_title":"DEVICE Recall: Mint Medical GmbH — Mint Lesion;  Software Versions: 3.4.0 up to 3.9.5.;","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-01-07","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2068-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Mint Medical GmbH"},"word_count":111,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2068-2026\n\n**Recalling firm:** Mint Medical GmbH\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-01-07\n**Report date:** 2026-05-13\n\n## Product\nMint Lesion;  Software Versions: 3.4.0 up to 3.9.5.;\n\n## Reason\nIf 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.\n\n## Affected lots\nSoftware Versions: 3.4.0 up to 3.9.5. UDI-DI: 04260495880341, 04260495880358, 04260495880365, 04260495880372, 04260495880389, 04260495880396.\n\n## Distribution\nWorldwide distribution - US Nationwide and the countries of Germany, Switzerland, Austria, Belgium, Italy, France, Romania, Netherlands, United Kingdom, Spain, Czech Republic, Ireland, Poland;"}