{
  "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": "Plainsboro",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "84216",
      "recalling_firm": "Integra LifeSciences Corp.",
      "address_1": "311 Enterprise Dr",
      "address_2": "N/A",
      "postal_code": "08536-3344",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US: AL AR AZ CA CO CT FL GA IA ID IL IN KS KY LA MA MD MI MN MO MS NC NE NJ NY OH OK OR PA SC TN UT VA WA WI WV    International: SG MX CA JP AU CO TH HK",
      "recall_number": "Z-0621-2020",
      "product_description": "C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System",
      "product_quantity": "820",
      "reason_for_recall": "The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.",
      "recall_initiation_date": "20191021",
      "center_classification_date": "20191208",
      "termination_date": "20200507",
      "report_date": "20191218",
      "code_info": "German OPS Manual   P/N 60905772",
      "more_code_info": ""
    }
  ]
}