{
  "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": "Mentor",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "74590",
      "recalling_firm": "US Endoscopy Group Inc",
      "address_1": "5976 Heisley Rd",
      "address_2": "N/A",
      "postal_code": "44060-1873",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Distribution to the states of :  OH, OR, WA  and Internationally to the country of Italy.",
      "recall_number": "Z-0289-2017",
      "product_description": "Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060    A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flexible endoscopes",
      "product_quantity": "36 units",
      "reason_for_recall": "US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was identified that the lot was incorrectly distributed.  The lot was assembled with internal catheter components which differ from the original Vari-Safe needle internal catheter components.  All components are dimensionally similar to the original Vari-Safe needle internal catheter components and the components have history of use on other US Endoscopy needle products.",
      "recall_initiation_date": "20160518",
      "center_classification_date": "20161019",
      "termination_date": "20170510",
      "report_date": "20161026",
      "code_info": "Model #: 00711819; Lot 1520268"
    }
  ]
}