{
  "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": "Ongoing",
      "city": "Mansfield",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86001",
      "recalling_firm": "Covidien Llc",
      "address_1": "15 Hampshire St",
      "address_2": "",
      "postal_code": "02048-1113",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "world wide distribution",
      "recall_number": "Z-2769-2020",
      "product_description": "Beacon EUS Access System Preloaded Access 135degree  Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.",
      "product_quantity": "269 units",
      "reason_for_recall": "This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detached cannula include delay in treatment, biliary leak, pain and retained device fragments.",
      "recall_initiation_date": "20200626",
      "center_classification_date": "20200805",
      "report_date": "20200812",
      "code_info": "Model # DSA-135-01  UDI: 10884521663527  Lot #: F2510371X, F2510861X, F2512341X, F2512383X, F2512493X, F2513453X",
      "more_code_info": ""
    }
  ]
}