{
  "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": "Miami Lakes",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "68834",
      "recalling_firm": "Cordis Corporation",
      "address_1": "14201 Nw 60th Ave",
      "address_2": "N/A",
      "postal_code": "33014-2802",
      "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 including Puerto Rico and the states of  AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC,  ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV,  WY and Hawaii., and the countries of Argentina, Brazil, Canada, Chile, Colombia, Mexico, Panama and Venezuela.",
      "recall_number": "Z-2557-2014",
      "product_description": "Cordis EMPIRA RX PTCA Dilatation Catheter",
      "product_quantity": "250,000 units.",
      "reason_for_recall": "The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover.  This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery.",
      "recall_initiation_date": "20140623",
      "center_classification_date": "20140828",
      "termination_date": "20161214",
      "report_date": "20140903",
      "code_info": "70 Catalog numbers:   85R06150S, 85R06200S, 85R06225S, 85R06250S, 85R06275S, 85R06300S,   85R06325S, 85R06350S, 85R06375S, 85R06400S, 85R10150S, 85R10200S,  85R10225S,85R10250S, 85R10275S, 85R10300S, 85R10325S, 85R10350S,  85R10375S, 85R10400S, 85R12150S, 85R12200S, 85R12225S, 85R12250S,  85R12275S, 85R12300S, 85R12325S, 85R12350S, 85R12375S, 85R12400S,  85R15150S, 85R15200S, 85R15225S, 85R15250S, 85R15275S, 85R15300S,  85R15325S, 85R15350S, 85R15375S, 85R15400S, 85R20150S, 85R20200S,  85R20225S, 85R20250S, 85R20275S, 85R20300S, 85R20325S, 85R20350S,  85R20375S, 85R20400S, 85R25150S, 85R25200S, 85R25225S, 85R25250S,  85R25275S, 85R25300S, 85R25325S, 85R25350S, 85R25375S, 85R25400S,  85R30150S, 85R30200S, 85R30225S, 85R30250S, 85R30275S, 85R30300S  85R30325S, 85R30350S, 85R30375S, and 85R30400S."
    }
  ]
}