{
  "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": [
    {
      "country": "United States",
      "city": "South Jordan",
      "address_1": "1600 West Merit Parkway",
      "reason_for_recall": "Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038.",
      "address_2": "",
      "product_quantity": "1,445",
      "code_info": "Catalo Number PR0-6F-11-038, Lot Number H767887",
      "center_classification_date": "20150622",
      "distribution_pattern": "Worldwide Distribution - US including TN, NE, MA, SC, WI, UT and Internationally to Belgium, Switzerland, United Kingdom, and Germany.",
      "state": "UT",
      "product_description": "Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO  The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.",
      "report_date": "20150701",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Merit Medical Systems, Inc.",
      "recall_number": "Z-1826-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "71519",
      "termination_date": "20151026",
      "more_code_info": "",
      "recall_initiation_date": "20150604",
      "postal_code": "84095",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}