{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "93881",
      "recalling_firm": "Integra LifeSciences Corp.",
      "address_1": "1100 Campus Rd",
      "address_2": "",
      "postal_code": "08540-6650",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Austria, Bahamas, Belgium,  Canada, Chile, France, Germany, Greece, Ireland, Israel, Poland, Portugal, Slovenia,  South Africa, Spain, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the).",
      "recall_number": "Z-1201-2024",
      "product_description": "Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.",
      "product_quantity": "8906 units",
      "reason_for_recall": "A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.",
      "recall_initiation_date": "20240119",
      "center_classification_date": "20240228",
      "report_date": "20240306",
      "code_info": "UDI: 10381780263968 Lot Number  Exp: Date:   6631603 1-Sep-23  6631604 1-Sep-23  6710212 1-Sep-23  6710213 1-Sep-23  6788598 1-Sep-23  6788599 1-Dec-23  6788600 1-Jan-24  6896383 1-Dec-23  6896384 1-Jan-24  6896385 1-Jan-24  6955153 17-Mar-24  6955154 17-Mar-24  6955155 17-Mar-24  7000260 17-Mar-24  7000261 17-Mar-24  7000262 17-Mar-24  7028225 17-Mar-24  7028226 17-Mar-24  7028227 1-Apr-24  7073035 1-Apr-24  7073036 1-Apr-24  7073037 1-Apr-24  7124699 1-Apr-24  7124700 1-Apr-24  7124702 1-Apr-24  7249008 1-Jun-24  7249009 1-Jun-24  7257038 1-Jun-24  7257039 1-Jun-24  7257040 1-Jun-24",
      "more_code_info": ""
    }
  ]
}