{"url_path":"/fda/device/recalls/Z-2768-2026","section_key":"summary","section_title":"DEVICE Recall: Medtronic Neurosurgery — Ventriculostomy Kit, REF: 46154","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-06-17","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2768-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Medtronic Neurosurgery"},"word_count":106,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2768-2026\n\n**Recalling firm:** Medtronic Neurosurgery\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-06-17\n**Report date:** 2026-07-29\n\n## Product\nVentriculostomy Kit, REF: 46154\n\n## Reason\nVentriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with cerebrospinal fluid; endotoxin exposure can cause an acute inflammatory process.\n\n## Affected lots\nUDI-DI: 00673978947396, Lot: 2025-08779\n\n## Distribution\nWorldwide - US Nationwide distribution in the states of UT, AL, CA, NC, GA, AR, LA, KY, LA, KY, IL, OK and the country of Costa Rica."}