{
  "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,
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  "results": [
    {
      "status": "Ongoing",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "94622",
      "recalling_firm": "Integra LifeSciences Corp.",
      "address_1": "1100 Campus Rd",
      "address_2": "N/A",
      "postal_code": "08540-6650",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the state of TX and the countries of Canada,  China, Croatia, Hungary, Russia, Singapore, Slovenia, South Africa, Taiwan (Province of China), Turkey",
      "recall_number": "Z-2138-2024",
      "product_description": "CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume.  Product Number: 821750",
      "product_quantity": "59 units",
      "reason_for_recall": "Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.",
      "recall_initiation_date": "20240507",
      "center_classification_date": "20240612",
      "report_date": "20240619",
      "code_info": "UDI-DI: 10381780518457 Lot Numbers: 7314916, 7314917, 7322939, 7328498, 7328563, 7328566, 7328569"
    }
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}