{
  "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-2106-2025",
      "product_description": "Torflex Transseptal Guiding Sheath Kit (TFK-M)    TF85-32-63-45  TORFLEX 8.5F 63CM 45DEG    TF85-32-63-55  TORFLEX 8.5F 63CM 55DEG    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": "TF85-32-63-45 UDI-DI 00685447005391 Lots 35508747 35644132 35746496 35913449;  TF85-32-63-55 UDI-DI 00685447005407 Lots 35508748 35738145",
      "more_code_info": ""
    }
  ]
}