{
  "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": "Tempe",
      "state": "AZ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99655",
      "recalling_firm": "Stryker Sustainability Solutions",
      "address_1": "1810 W Drake Dr",
      "address_2": "N/A",
      "postal_code": "85283-4327",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the state of NJ.",
      "recall_number": "Z-0085-2027",
      "product_description": "BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007",
      "product_quantity": "10",
      "reason_for_recall": "Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate matter.",
      "recall_initiation_date": "20260818",
      "center_classification_date": "20261005",
      "report_date": "20261014",
      "code_info": "UDI-DI: 00885825003838. Lot: 5640704, Serial: 5097742, Distribution Date: May 26th 2026"
    }
  ]
}