{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Changchun",
      "state": "N/A",
      "country": "China",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97801",
      "recalling_firm": "Changchun Wancheng Bio-Electron Co., Ltd.",
      "address_1": "2336, Tianwei Road",
      "address_2": "Beihu Science and Technology Development Zone",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the states of TX, GA, CA.",
      "recall_number": "Z-1263-2026",
      "product_description": "Exploro Highly Sensitive Male Fertility / Sperm Concentration Test",
      "product_quantity": "4,800",
      "reason_for_recall": "Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.",
      "recall_initiation_date": "20251122",
      "center_classification_date": "20260204",
      "report_date": "20260211",
      "code_info": "Name/Lot(Expiration): Exploro Highly Sensitive Male Fertility / Sperm Concentration Test/2025033101(03-30-2027), 2025080801(08-07-2027), 2025090844(09-07-2027)"
    }
  ]
}