{
  "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": [
    {
      "country": "United States",
      "city": "Elkton",
      "address_1": "950 Elkton Blvd",
      "reason_for_recall": "Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Destination¿ products may not contain the labeled 5 cm of coating.  While there have been no complaints or patient related incidents reported, the lack of coating could render it  difficult to navigate the device to the target vasculature.",
      "address_2": "",
      "product_quantity": "5,252 eaches",
      "code_info": "Terumo Product  Code - RSR01    Affected Lot  Numbers    RN19   RN26   RP03",
      "center_classification_date": "20170504",
      "distribution_pattern": "Nationwide Distribution.",
      "state": "MD",
      "product_description": "Destination Renal Guiding Sheath    Intended for the introduction of interventional and diagnostic devices into the human vasculature.",
      "report_date": "20170510",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Terumo Medical Corporation",
      "recall_number": "Z-2033-2017",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "76939",
      "termination_date": "20170512",
      "more_code_info": "",
      "recall_initiation_date": "20151106",
      "postal_code": "21921-5322",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}