{
  "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": "Bloomington",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81238",
      "recalling_firm": "Cook Medical Incorporated",
      "address_1": "400 N Daniels Way",
      "address_2": "N/A",
      "postal_code": "47404-9155",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide Distribution  in the states of:  AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico.",
      "recall_number": "Z-0325-2019",
      "product_description": "Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-125-12.0-40      Product Usage:  The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.",
      "product_quantity": "9834 total",
      "reason_for_recall": "The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.",
      "recall_initiation_date": "20180925",
      "center_classification_date": "20181031",
      "termination_date": "20200604",
      "report_date": "20181107",
      "code_info": "GPN: G36239"
    }
  ]
}