{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Boca Raton",
      "state": "FL",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63319",
      "recalling_firm": "Vycor Medical, Inc.",
      "address_1": "6401 Congress Ave Ste 140",
      "address_2": "N/A",
      "postal_code": "33487-2841",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide Distribution - USA (Nationwide) in the states of TX, IL, NJ, FL, OH, PA and (International) in the country of Japan.",
      "recall_number": "Z-0673-2013",
      "product_description": "Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE***    Product Usage:  The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes.",
      "product_quantity": "3000 devices",
      "reason_for_recall": "Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.",
      "recall_initiation_date": "20120821",
      "center_classification_date": "20130116",
      "termination_date": "20130513",
      "report_date": "20130123",
      "code_info": "Model # TC171105  Lot # VM83450"
    }
  ]
}