{"url_path":"/fda/device/recalls/Z-2148-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline medical convenience kits, containing Namic Manifold, Labeled as:  TAVI, Medline Kit Number/SKU DYNJ904981C","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-24","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2148-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Medline Industries, LP"},"word_count":86,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2148-2026\n\n**Recalling firm:** Medline Industries, LP\n**Classification:** Class I\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-24\n**Report date:** 2026-05-20\n\n## Product\nMedline medical convenience kits, containing Namic Manifold, Labeled as:  TAVI, Medline Kit Number/SKU DYNJ904981C\n\n## Reason\nMedline has identified the presence of particulate within the fluid path of the Manifolds.\n\n## Affected lots\nUDI/DI each 10193489475135, UDI/DI case 40193489475136, Lot Numbers:  23GBR742, 23IBC951, 23JBM554, 23LBK506, 24BBO670, 24GBM624.\n\n## Distribution\nUS (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK."}