{
  "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": "Somerset",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77661",
      "recalling_firm": "Terumo Medical Corp",
      "address_1": "2101 Cottontail Ln",
      "address_2": "N/A",
      "postal_code": "08873-1277",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Canada",
      "recall_number": "Z-0230-2018",
      "product_description": "Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product Code RM*RS7F16PA, STERILE, Rx ONLY",
      "product_quantity": "N/A",
      "reason_for_recall": "An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units).  This breach of the sterile barrier may compromise the sterility of the sheath.",
      "recall_initiation_date": "20170607",
      "center_classification_date": "20171208",
      "termination_date": "20190425",
      "report_date": "20171220",
      "code_info": "Lot s 161019, 161108, 161215, 170112, 170213, 170314"
    }
  ]
}