{"url_path":"/fda/device/recalls/Z-2615-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Reprocessed Electrophysiology Catheters and Ultrasound Catheters    Item no. 401206RH,\tSt. Jude Medical Response\" Diagnostic Electrophysiology Catheter 4 Elec. 10mm;    Item no. 401305RH,\tSt. Jude Medical Response\" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-15","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2615-2026%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":160,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2615-2026\n\n**Recalling firm:** Medline Industries, LP\n**Classification:** Class I\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-15\n**Report date:** 2026-07-08\n\n## Product\nReprocessed Electrophysiology Catheters and Ultrasound Catheters    Item no. 401206RH,\tSt. Jude Medical Response\" Diagnostic Electrophysiology Catheter 4 Elec. 10mm;    Item no. 401305RH,\tSt. Jude Medical Response\" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.\n\n## Reason\nExpansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.\n\n## Affected lots\nLot EP250203  Item no. 401206RH - UDI-DI 10197344043767; Item no. 401305RH - UDI-DI 10197344043637.\n\n## Distribution\nUS Nationwide distribution in the state of TX."}