{"recall":{"id":"fda-device-99342","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Medtronic Neurosurgery recalls Ventriculostomy Kit","firm":"Medtronic Neurosurgery","date":"2026-06-17","reported":"2026-07-29","status":"Ongoing","classification":"Class II","products":[{"name":"Ventriculostomy Kit, REF: 46154","code":"UDI-DI: 00673978947396, Lot: 2025-08779","quantity":"167","number":"Z-2768-2026","classification":"Class II"}],"reason":"Ventriculostomy 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.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - 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.","nationwide":true,"states":[],"units":"167","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99342","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"c4165224596794ce","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99342","record":[{"status":"Ongoing","city":"Haltom City","state":"TX","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99342","recalling_firm":"Medtronic Neurosurgery","address_1":"4620 N Beach St","address_2":"N/A","postal_code":"76137-3219","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - 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.","recall_number":"Z-2768-2026","product_description":"Ventriculostomy Kit, REF: 46154","product_quantity":"167","reason_for_recall":"Ventriculostomy 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.","recall_initiation_date":"20260617","center_classification_date":"20260721","report_date":"20260729","code_info":"UDI-DI: 00673978947396, Lot: 2025-08779"}]}}