{
  "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": "San Clemente",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85300",
      "recalling_firm": "ICU Medical, Inc.",
      "address_1": "951 Calle Amanecer",
      "address_2": "N/A",
      "postal_code": "92673-6212",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide Distribution in the states of  FL, WI, NY, NC, VT, IL, MD, CA, NE, WA  OUS: None",
      "recall_number": "Z-1835-2020",
      "product_description": "ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499",
      "product_quantity": "83 units",
      "reason_for_recall": "Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System.  These issues may result in inaccurate monitoring data, unit shutdown, and/or loss of display of a secondary parameter.",
      "recall_initiation_date": "20190712",
      "center_classification_date": "20200430",
      "termination_date": "20230510",
      "report_date": "20200506",
      "code_info": "All serial numbers of Cogent HMS, PN 58400-000, PN 58400-000R (User Interface Module (UIM), PN 58403-000 and Patient Interface Module (PIM), PN 58401-000) with Software Versions 1.3.2.460 and prior are impacted."
    }
  ]
}