{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Powell",
      "state": "TN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77519",
      "recalling_firm": "DeRoyal Industries Inc",
      "address_1": "200 Debusk Ln",
      "address_2": "N/A",
      "postal_code": "37849-4703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution to MD, NY, and IL",
      "recall_number": "Z-2639-2017",
      "product_description": "DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO,    Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.",
      "product_quantity": "426 units",
      "reason_for_recall": "Lack of sterility assurance.  There is a defect in the primary packaging of the device, which may compromise the device sterility",
      "recall_initiation_date": "20170607",
      "center_classification_date": "20170629",
      "termination_date": "20200722",
      "report_date": "20170705",
      "code_info": "Lot Number 15125173"
    }
  ]
}