{
  "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-2105-2025",
      "product_description": "VersaCross Transseptal Sheath Kit (VXS)  Product Description/IDs  VXS0201  VXS 63CM/45DEG/D0 SHEATH    VXS2112  VERSACROSS SHEATH (63CM 45DEG D0)-J    Used for the percutaneous introduction of various types of  cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal  perforation / puncture.",
      "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": "VXS0201 UDI-DI 00685447020301 Lot 35800622;  VXS2112 UDI-DI 00685447019251 Lot 35892045",
      "more_code_info": ""
    }
  ]
}