{
  "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": "Ongoing",
      "city": "Republic",
      "state": "MO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87472",
      "recalling_firm": "ROi CPS LLC",
      "address_1": "3000 E Sawyer Rd",
      "address_2": "N/A",
      "postal_code": "65738-2758",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution in the state of Missouri.",
      "recall_number": "Z-1376-2021",
      "product_description": "Regard, Item Number 830067009, custom cardiovascular procedure kit",
      "product_quantity": "16 kits",
      "reason_for_recall": "ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer procedure trays may have slits in the product that may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment.",
      "recall_initiation_date": "20210304",
      "center_classification_date": "20210408",
      "report_date": "20210414",
      "code_info": "Lot number: 75818I; Expiration Date: 05/18/2021"
    }
  ]
}