{
  "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": [
    {
      "country": "United States",
      "city": "Campbell",
      "address_1": "745 Camden Ave Ste A",
      "reason_for_recall": "Torn sheath liner material was detected at the proximal end of the device during internal product testing which may be the result of damage incurred during the manufacturing process.",
      "address_2": "",
      "product_quantity": "99 sheaths",
      "code_info": "Lot #0559, exp. 10/9/2018, and Lot #0571, exp. 10/19/2018.",
      "center_classification_date": "20180209",
      "distribution_pattern": "Distribution was made to DC, FL, GA, MD, MI, NJ, NY, OH, PA, SC, and VA.  There was also military/government distribution.  There was no foreign distribution.",
      "state": "CA",
      "product_description": "Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx.  The firm name on the label is Kalila Medical, Campbell, CA.",
      "report_date": "20180221",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Kalila Medical",
      "recall_number": "Z-0563-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "78824",
      "termination_date": "20181214",
      "more_code_info": "",
      "recall_initiation_date": "20171214",
      "postal_code": "95008-4146",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}