{
  "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": "2026-03-18",
    "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": "90984",
      "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": "Distribution was made to CA, IL, KY, OH, OK, RI, TX.  There was no government/military distribution.  Foreign distribution was made to Chile and Hong Kong.",
      "recall_number": "Z-0149-2023",
      "product_description": "EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.",
      "product_quantity": "16 consoles",
      "reason_for_recall": "Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.",
      "recall_initiation_date": "20221013",
      "center_classification_date": "20221028",
      "report_date": "20221109",
      "code_info": "Serial numbers CU4.0-01438, CU4.0-01524, CU4.0-01545, CU4.0-01560, CU4.0-01598, CU4.0-01610, CU4.0-01676, CU4.0-01804, CU4.0-01835, CU4.0-01840, CU4.0-01843, CU4.0-01897, CU4.0-01980, CU4.0-02022, CU4.0-02146, and CU4.0-02026, UPN 600-40500, GTIN 00858593006462."
    }
  ]
}