{
  "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": [
    {
      "country": "United States",
      "city": "Bothell",
      "address_1": "11911 N Creek Pkwy S",
      "reason_for_recall": "The recalling firm identified ten devices which were distributed and could potentially be non-compliant.  These devices potentially underwent a routine manufacturing test with non-compliant parameters, which may result in a small blister in the epoxy over transducers in the treatment zone.  It is not known at the time the recall was initiated whether the non-compliant test parameters, or presence of the blisters, adversely affect operation of the device.",
      "address_2": "",
      "product_quantity": "10 units",
      "code_info": "Table 1: Device Identification Information  Catalog Number; Lot Number; Serial Number; Expiration Date  500-5518;              160711017; 160711017-005; 06-30-2019  500-5518;              160711017; 160711017-006; 06-30-2019.  500-5518;              160711017; 160711017-003; 06-30-2019.  500-5518;              160711017; 160711017-004; 06-30-2019.  500-5512;              160711042; 160711042-010; 06-30-2019.  500-5518;              160711017; 160711017-001; 06-30-2019.  500-5518;              160711017; 160711017-002; 06-30-2019.  500-5518;              160711017; 160711017-007; 06-30-2019.  500-5518;              160711017; 160711017-008; 06-30-2019.  500-5518;              160711017; 160711017-009; 06-30-2019.    3001627457 \u0013 08/09/2016-002R  CONFIDENTIAL 3  ¿ Name, address, and type of responsible firm on label; number and description of private labels.  Manufacturer:  EKOS Corporation  11911 North Creek Parkway South  Bothell, WA 98011  ¿ Collect a complete copy of all labeling (include product inserts, information sheets.)  Applicable labeling is included in Attachment 1.  B. CODE:  ALL lot and/or serial numbers, batch numbers, catalog numbers, product numbers, packer or  manufacturer numbers, etc., exactly as they appear on the product, container, or labeling.  There are 10 total devices in distribution. Identification information for the implicated devices is  found in Table 1:  Table 1: Device Identification Information  Catalog Number Lot Number Serial Number Expiration Date  500-5518 160711017 160711017-005 06-30-2019  500-5518 160711017 160711017-006 06-30-2019  500-5518 160711017 160711017-003 06-30-2019  500-5518 160711017 160711017-004 06-30-2019  500-5512 160711042 160711042-010 06-30-2019  500-5518 160711017 160711017-001 06-30-2019  500-5518 160711017 160711017-002 06-30-2019  500-5518 160711017 160711017-007 06-30-2019  500-5518 160711017 160711017-008 06-30-2019  500-5518 160711017 160711017-009 06-30-2019  ¿ Give a breakdown of the code  Catalog Number consists of 7 digits (XXX-YYYY), where;  ¿ XXX represents a product family,  ¿ YYYY represents a specific configuration, such as working length/treatment zone length.",
      "center_classification_date": "20160921",
      "distribution_pattern": "Three international consignees - Germany, New Zealand and Taiwan",
      "state": "WA",
      "product_description": "EkoSonic Endovascular Devices    EKOS Intelligent Drug Delivery Catheter",
      "report_date": "20160928",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "EKOS Corporation",
      "recall_number": "Z-2854-2016",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "75046",
      "termination_date": "20161005",
      "more_code_info": "",
      "recall_initiation_date": "20160809",
      "postal_code": "98011-8809",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}