{
  "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": [
    {
      "country": "United States",
      "city": "Lawrenceville",
      "address_1": "1665 Lakes Pkwy",
      "reason_for_recall": "Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.",
      "address_2": "",
      "product_quantity": "1,031 cases (12,372 units)",
      "code_info": "Catalog Number: ISEPT-450-USA; Lot Numbers: 19CAB939, 19DAB431; Expiration Date: 2021-04-30",
      "center_classification_date": "20191023",
      "distribution_pattern": "Nationwide distribution to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV.",
      "state": "GA",
      "product_description": "Irrisept Wound Debridement and Cleansing System. 12 units per case.",
      "report_date": "20191030",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "IrriMAX Corporation",
      "recall_number": "Z-0191-2020",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "83599",
      "termination_date": "20200925",
      "more_code_info": "",
      "recall_initiation_date": "20190816",
      "postal_code": "30043-5881",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}