{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Mentor",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91020",
      "recalling_firm": "Steris Corporation",
      "address_1": "5960 Heisley Rd",
      "address_2": "N/A",
      "postal_code": "44060-1834",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the states of Arizona, Illinois, Tennessee, Virginia.",
      "recall_number": "Z-0241-2023",
      "product_description": "GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas, in flexible endoscopic applications.    MODEL #(s): G1110001",
      "product_quantity": "5 units",
      "reason_for_recall": "Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit board assembly may result in premature wear of the power regulator, leading to the regulator\u0019s failure which could cause a full power loss. If the regulator failure were to occur during a patient procedure, a procedural delay may result",
      "recall_initiation_date": "20221017",
      "center_classification_date": "20221116",
      "termination_date": "20240528",
      "report_date": "20221123",
      "code_info": "UDI: 00724995180256 Serial Numbers: 0032-0822-003, 0032-0622-009, 0032-0922-001, 0032-0822-001, and 0032-0082-002"
    }
  ]
}