{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Sunnyvale",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87196",
      "recalling_firm": "Silk Road Medical Inc",
      "address_1": "1213 Innsbruck Dr",
      "address_2": "N/A",
      "postal_code": "94089-1317",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "U.S.: AZ, CA, CO, CT, DC, DE, FL, GA, HI, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV.    O.U.S.: None",
      "recall_number": "Z-1146-2021",
      "product_description": "ENROUTE Transcarotid Stent System REF SR-XXYY-CS",
      "product_quantity": "Total = 455 systems",
      "reason_for_recall": "Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.",
      "recall_initiation_date": "20210113",
      "center_classification_date": "20210223",
      "termination_date": "20230131",
      "report_date": "20210303",
      "code_info": "Catalog Number: SR0930CS  UDI Code: (01)00811311020492(17)211130(10)17917092  Lot Number: 17917092    Catalog Number: SR0930CS  UDI Code: (01)00811311020492(17)211231(10)17923717  Lot Number: 17923717    Catalog Number: SR1030CS  UDI Code: (01)00811311020522(17)220131(10)17929776  Lot Number: 17929776    Catalog Number: SR1040CS  UDI Code: (01)00811311020539(17)220131(10)17931107  Lot Number: 17931107    Catalog Number: SR0940CS  UDI Code: (01)00811311020508(17)230131(10)301576  Lot Number: 301576"
    }
  ]
}