{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Raynham",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82403",
      "recalling_firm": "Medrobotics Corporation",
      "address_1": "475 Paramount Dr",
      "address_2": "N/A",
      "postal_code": "02767-5178",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of  CO, DC, FL, IL, MD, MO, NY, OK, PA, TX, and VA. Foreign distribution to Australia and Italy.",
      "recall_number": "Z-1191-2019",
      "product_description": "Obturator (long cone), Part number 25162    Product Usage:  The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, rectum and distal colon. The Flex Robotic System is intended for use in adults (e22 years of age). The Flex Colorectal Drive is intended for robot-assisted visualization of and surgical site access to the anus, rectum, and distal colon in adults (e22 years of age). The Flex Colorectal Drive also provides accessory channels for compatible flexible instruments used in surgery.",
      "product_quantity": "35",
      "reason_for_recall": "The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.",
      "recall_initiation_date": "20190125",
      "center_classification_date": "20190417",
      "termination_date": "20201211",
      "report_date": "20190424",
      "code_info": "lots 18832-17, 19042-07, 19042-01, 19199-01, 18832-17, 19669-05, 19684-05"
    }
  ]
}