{
  "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": "Palm Harbor",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "75785",
      "recalling_firm": "Oscor, Inc.",
      "address_1": "3816 Desoto Blvd",
      "address_2": "N/A",
      "postal_code": "34683-1618",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM",
      "recall_number": "Z-0796-2017",
      "product_description": "OSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM Catalog # AB081046  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.",
      "product_quantity": "61",
      "reason_for_recall": "Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.",
      "recall_initiation_date": "20161005",
      "center_classification_date": "20161219",
      "termination_date": "20190726",
      "report_date": "20161228",
      "code_info": "Lot #'s: OR-04632 Exp. March 10, 2018, OR-04632 Exp. March 10, 2018,  OR-04632 Exp. March 10, 2018, OR-04692 Exp. July 16, 2018, OR-04692 Exp. July 16, 2018, C1-11635 Exp. September 29, 2018,  OR-04632 Exp. March 10, 2018,  OR-04632 Exp. March 10, 2018,  OR-04692 Exp. July 16, 2018,  OR-04692 Exp. July 16, 2018, OR-04692 Exp. July 16, 2018, and C1-09412 Exp. December 1, 2017"
    }
  ]
}