{
  "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-0795-2017",
      "product_description": "OSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM  Catalog # AB081045  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.",
      "product_quantity": "76",
      "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: C1-09374 Exp. November 5, 2017,  C1-10319 Exp. May 11, 2018, C1-11202 Exp. August 24, 2018,  C1-11202 Exp. August 24, 2018,  C1-11671 Exp. September 30, 2018,  C1-11671 Exp. September 30, 2018,  C1-11202 Exp. August 24, 2018, C1-11671 Exp. September 30, 2018,  C1-11672 Exp. September 30, 2018,  and C1-09374 Exp. November 5, 2017"
    }
  ]
}