{
  "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-0109-2027",
      "product_description": "ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A",
      "product_quantity": "32,184 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 ePM Series Patient Monitors Operator's Manuals: 1. Guardian Plus Operator's Manual (OEM, MDPro) up to and including revision 4.0; Part No. 046-026408-00  2. ePM 10A Operator's Manual up to and including revision 12.0; Part No. 046-019796-00  3.  ePM 12MA Operator's Manual up to and including revision 13.0; Part No. 046-019797-00  4.  ePM 10M, ePM 12M Operator's Manual up to and including revision 13.0; Part No. 046-019798-00  5.  ePM 15M Operator's Manual up to and including revision 3.0; Part No. 046-028915-00"
    }
  ]
}