{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-03",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
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      "cfres_id": "221365",
      "product_res_number": "Z-2768-2026",
      "event_date_initiated": "2026-06-17",
      "event_date_posted": "2026-07-21",
      "recall_status": "Open, Classified",
      "res_event_number": "99342",
      "product_code": "HBG",
      "k_numbers": [
        "K915546"
      ],
      "product_description": "Ventriculostomy Kit, REF: 46154",
      "code_info": "UDI-DI: 00673978947396, Lot: 2025-08779",
      "firm_fei_number": "3015531529",
      "recalling_firm": "Medtronic Neurosurgery",
      "address_1": "4620 N Beach St",
      "city": "Haltom City",
      "state": "TX",
      "postal_code": "76137-3219",
      "additional_info_contact": "Christine Stewart\n269-377-2557",
      "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.",
      "root_cause_description": "Process control",
      "action": "On 6/17/2026, recall notices were mailed and emailed to customers asking them to do the following:\n1) Identify, quarantine, and return affected devices to the firm.\n2) Complete and return the Customer Confirmation Form via email to neuro.quality@medtronic.com\n3) This notice should be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred.\n\nFor additional information, email the firm at rs.mnsprodexperiencehelp@medtronic.com",
      "product_quantity": "167",
      "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.",
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        "device_name": "Drills, Burrs, Trephines & Accessories (Manual)",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.4300",
        "device_class": "2"
      }
    }
  ]
}