{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Fremont",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80353",
      "recalling_firm": "Stryker Neurovascular",
      "address_1": "47900 Bayside Pkwy",
      "address_2": "N/A",
      "postal_code": "94538-6515",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "Z-2569-2018",
      "product_description": "FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)",
      "product_quantity": "968 units",
      "reason_for_recall": "There may be product manufactured with the outer diameter of the balloon catheter exceeding the defined specification at a customer location. If the user experiences resistance between the FlowGate and an interfacing device, the device would be removed and a second device would be used, which could potentially prolong a procedure.",
      "recall_initiation_date": "20180411",
      "center_classification_date": "20180728",
      "termination_date": "20210428",
      "report_date": "20180808",
      "code_info": "Lots 1352, 1630, 1631, 1802, 1970, 2652, 2653, 2654, 2655, 2656, 2657, 2658, 2659, 3169, 3940, 3941"
    }
  ]
}