{
  "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": {
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      "city": "Maple Grove",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
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      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "1 Scimed Pl",
      "address_2": "",
      "postal_code": "55311-1565",
      "voluntary_mandated": "Voluntary: Firm initiated",
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      "recall_number": "Z-3148-2024",
      "product_description": "Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail",
      "product_quantity": "32 units",
      "reason_for_recall": "There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.",
      "recall_initiation_date": "20240718",
      "center_classification_date": "20240913",
      "report_date": "20240925",
      "code_info": "GTIN/UDI 0871472932327, Lot # 33512376, exp. 02/26/2027",
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}