{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Bloomington",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "84108",
      "recalling_firm": "Cook Inc.",
      "address_1": "750 N Daniels Way",
      "address_2": "N/A",
      "postal_code": "47404-9120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "No US distribution.    The products were distributed to the following foreign countries:  Belgium, Denmark, Germany, Italy, Netherlands, Norway, Poland, Republic of Macedonia, Slovenia, Spain, and Switzerland.",
      "recall_number": "Z-0416-2020",
      "product_description": "Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity.",
      "product_quantity": "400",
      "reason_for_recall": "Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter.  Potential adverse events that may occur if an affected product is used include increased procedural time, the need for a repeat embryo transfer procedure, or the need for a patient to undergo an additional IVF cycle.",
      "recall_initiation_date": "20191003",
      "center_classification_date": "20191116",
      "termination_date": "20200513",
      "report_date": "20191127",
      "code_info": "Lot Number 8361746"
    }
  ]
}