{"url_path":"/fda/device/recalls/Z-2138-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.","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-2138-2026%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":108,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2138-2026\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\nNamic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.\n\n## Reason\nMedline has identified the presence of particulate within the fluid path of the Manifolds.\n\n## Affected lots\nUDI/DI each 10193489059144, UDI/Di case 30193489059148, Lot Numbers:  90184, 94779, 97786, 106351, 108597, 109876, 114056, 114989, 115459, 115931, 116358, 116865, 118245, 122974, 126077, 127795, 129531, 130557, 136114, 150501, 151591, 152772, 154514, 156045, 160318, 163255, 168053.\n\n## Distribution\nUS (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK."}