{
  "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": "2026-10-14",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99828",
      "recalling_firm": "Mindray DS USA, Inc.",
      "address_1": "800 Macarthur Blvd",
      "address_2": "N/A",
      "postal_code": "07430-2001",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - Nationwide and the country of Canada.",
      "recall_number": "Z-0114-2027",
      "product_description": "Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V",
      "product_quantity": "39,891 units",
      "reason_for_recall": "Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions",
      "recall_initiation_date": "20260831",
      "center_classification_date": "20261007",
      "report_date": "20261014",
      "code_info": "Part Numbers of Passport Series Patient Monitor Operator's Manuals: 1. Passport 8_12 Operator's Manual up to and including revision 13.0; Part No. 046-004417-00   2. Passport 17M 12M Operator's Manual up to and including revision 17.0; Part No. 046-005013-00  3. Passport V Patient Monitors Operating Instructions up to and including revision 10.0; Part No. 0070-00-0704-02"
    }
  ]
}