{
  "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": "85292",
      "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": "Letter",
      "distribution_pattern": "U.S.:  NV, IL, VA, PA, CA, AR, MA, GA, OH, NJ, TX, FL, NC, SC, MI, NH, CO, AL, MN, KS, NM, AZ, ID, MD, NY, OR, DC, DE, MO, IN, WI, IA, TN.    O.U.S.:   Switzerland, Hong Kong, Spain, Portugal, Canada, Singapore, United Arab Emirates, Mexico, United Kingdom, France, Japan, Germany, Italy",
      "recall_number": "Z-1796-2020",
      "product_description": "PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT",
      "product_quantity": "1932",
      "reason_for_recall": "During the sterilization of radial compression devices, some of the inflatable balloons may break or burst, which may result in air leakage and the inability to maintain pressure/compression. This may result in a lack of hemostasis resulting in bleeding or a delay in treatment; the defect is likely to be visually identified by the clinician before use or identified during inflation of the balloon.",
      "recall_initiation_date": "20200311",
      "center_classification_date": "20200424",
      "termination_date": "20220302",
      "report_date": "20200506",
      "code_info": "SDRB-REG-LT: Lot(UDI): H1559517(10884450363673) and H1727668(00884450363676).  SDRB-REG-RT: Lot(UDI): H1666548(10884450363659) and H1723973(10884450363659)"
    }
  ]
}