{
  "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": "Marlborough",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "96049",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "100 Boston Scientific Way",
      "address_2": "",
      "postal_code": "01752-1234",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide including Puerto Rico Foreign: To be provided",
      "recall_number": "Z-1032-2025",
      "product_description": "HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm  UPN: M00553520",
      "product_quantity": "263 units (OUS)",
      "reason_for_recall": "Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.",
      "recall_initiation_date": "20241220",
      "center_classification_date": "20250130",
      "report_date": "20250205",
      "code_info": "GTIN: 08714729904540 Lot Numbers: 33336402, 33336404, 33336405, 33336411, 33392916, 33392917, 33393302, 33411607, 33437479, 33548501, 33577903, 33704371, 33712822, 33986537, 34017087, 34017088, 34017089, 34028458, 34065579, 34065660, 34083271,  34083272",
      "more_code_info": ""
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}