{
  "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": "Saint Paul",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97036",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "4100 Hamline Ave N",
      "address_2": "N/A",
      "postal_code": "55112-5700",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.",
      "recall_number": "Z-2104-2025",
      "product_description": "VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart.    Product ID VXW0002    Device approved and commercialized in Japan only.",
      "product_quantity": "14,724",
      "reason_for_recall": "Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.",
      "recall_initiation_date": "20250610",
      "center_classification_date": "20250710",
      "report_date": "20250716",
      "code_info": "UDI-DI 00685447006121 Lot 35935598",
      "more_code_info": ""
    }
  ]
}