{
  "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": "South Jordan",
      "state": "UT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85342",
      "recalling_firm": "Merit Medical Systems, Inc.",
      "address_1": "1600 W Merit Pkwy",
      "address_2": "N/A",
      "postal_code": "84095-2416",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "US Nationwide distribution in the state of MI.",
      "recall_number": "Z-1956-2020",
      "product_description": "Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.",
      "product_quantity": "15 kits",
      "reason_for_recall": "labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging.  The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism.",
      "recall_initiation_date": "20190912",
      "center_classification_date": "20200511",
      "termination_date": "20220527",
      "report_date": "20200520",
      "code_info": "Catalog Number: K21-00031, Lot Number: H1583914,  UDI: 00884450426357"
    }
  ]
}