{
  "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": "Maple Grove",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97396",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "1 Scimed Pl",
      "address_2": "N/A",
      "postal_code": "55311-1565",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution.",
      "recall_number": "Z-2533-2025",
      "product_description": "Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN):    1.\tH74904526011;   2.\tH74904526052;   3.\tM0067101140;   4.\tM001151050;   5.\tM001151062;   6.\tM00566670.   (Interventional Cardiology, Peripheral Interventions)",
      "product_quantity": "39739 units",
      "reason_for_recall": "The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.",
      "recall_initiation_date": "20250805",
      "center_classification_date": "20250905",
      "report_date": "20250917",
      "code_info": "1. H74904526011, GTIN 8714729177029, Lot Numbers:  34915076, 35065978;  2. H74904526052, GTIN 8714729127062, Lot Numbers:  34915078, 34915220;  3. M0067101140, GTIN 8714729755814, Lot Numbers:  34892421;  4. M001151050, GTIN 8714729183624, Lot Numbers:  34966934;  5. M001151062, GTIN 8714729137542, Lot Numbers:  34873498;  6. M00566670, GTIN 8714729755241, Lot Numbers:  35045668."
    }
  ]
}