{
  "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": [
    {
      "status": "Terminated",
      "city": "Vernon Hills",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81399",
      "recalling_firm": "Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company",
      "address_1": "330 Corporate Woods Pkwy",
      "address_2": "N/A",
      "postal_code": "60061-3107",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, and WI",
      "recall_number": "Z-0490-2019",
      "product_description": "Irrisept OR, Finished Bottle Assembly 450 ml STEP 1",
      "product_quantity": "10,440",
      "reason_for_recall": "Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.",
      "recall_initiation_date": "20170905",
      "center_classification_date": "20181120",
      "termination_date": "20240923",
      "report_date": "20181128",
      "code_info": "Model # FB-A-400-107 Lot Number:  4J006",
      "more_code_info": ""
    }
  ]
}