{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Elkton",
      "state": "MD",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82705",
      "recalling_firm": "Terumo Medical Corporation",
      "address_1": "950 Elkton Blvd",
      "address_2": "N/A",
      "postal_code": "21921-5322",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "The products were distributed US nationwide.    The products were distributed to the following foreign countries:  Australia, Belgium, Brazil, Canada, Portugal, Hong Kong, Peru, Singapore.",
      "recall_number": "Z-1376-2019",
      "product_description": "Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19,   PRTSOLO-20",
      "product_quantity": "1481",
      "reason_for_recall": "There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.",
      "recall_initiation_date": "20190426",
      "center_classification_date": "20190528",
      "termination_date": "20200922",
      "report_date": "20190605",
      "code_info": "Lot Codes:  VG29  VH28  VK09  VM20  VN08  VP07  WM03  WM31  VG05  VG09  VG21  VK18  VL25  VM11  VN17  VN27  WM03  WM17"
    }
  ]
}