{
  "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-0816-2017",
      "product_description": "MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F  C70¿ S79CM D84CM GLOBAL  Catalog # 990079-070-000  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.",
      "product_quantity": "1,269",
      "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: C1-08310 Exp. October 29, 2016,  C1-08364 Exp. November 21, 2016,  C1-08606 Exp. February 20, 2017,  C1-08611 Exp. February 20, 2017,  C1-08802 Exp. April 3, 2017,  C1-08857 Exp. April 22, 2017,  C1-09091 Exp. July 10, 2017,  C1-09090 Exp. July 10, 2017,  C1-09859 Exp. March 5, 2018,  C1-09860 Exp. March 5, 2018,  C1-09880 Exp. March 11, 2018,  C1-09921 Exp. March 16, 2018,  C1-10039 Exp. April 5, 2018,  C1-10141 Exp. April 22, 2018,  C1-10141 Exp. April 22, 2018,  C1-10146 Exp. April 23, 2018, C1-10242 Exp. May 4, 2018,  C1-10240 Exp. May 4, 2018,  C1-10241 Exp. May 4, 2018, C1-11206 Exp. August 24, 2018, C1-11206 Exp. August 24, 2018, C1-11572 Exp. September 25, 2018,  C1-11572 Exp. September 25, 2018, C1-11850 Exp. October 16, 2018, and C1-11849 Exp. October 16, 2018"
    }
  ]
}