{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Bothell",
      "state": "WA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "73195",
      "recalling_firm": "EKOS Corporation",
      "address_1": "11911 N Creek Pkwy S",
      "address_2": "N/A",
      "postal_code": "98011-8809",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed in the states of AZ, CA, MA, MI, OH, and VA.",
      "recall_number": "Z-0864-2016",
      "product_description": "EkoSonic Endovascular System, Catalog Number 500-56112.    It consists of three main components, a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and removable MicroSonic Device (MSD), and a reusable EKOS EkoSonic Control System.     During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site.     The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Connector Interface  Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.",
      "product_quantity": "10 units",
      "reason_for_recall": "The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug Delivery Catheter (IDDC) are labeled with a 135 cm working length, and programmed with a 135 cm family code, however the MSD actual working length is 106 cm.",
      "recall_initiation_date": "20160121",
      "center_classification_date": "20160224",
      "termination_date": "20160315",
      "report_date": "20160302",
      "code_info": "Lot Number 150910004. Expiration date is August 15, 2018.    Serial numbers: 001, 002, 003, 004, 005, 006, 007, 008, 009, 010",
      "more_code_info": ""
    }
  ]
}