{
  "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": "2026-10-21",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99697",
      "recalling_firm": "Jenavalve Technology Inc.",
      "address_1": "4 Cromwell",
      "address_2": "",
      "postal_code": "92618-1816",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the states of AZ, CA, FL, GA, IL, MA,  MD, MI, MN, MO, NY, OH, PA, SC, TX, UT, VA, WA and the countries of Germany, Denmark, Great Britain, Italy.",
      "recall_number": "Z-0134-2027",
      "product_description": "JenaValve Trilogy Delivery Catheter, Size 23MM  REF: TRILOGY-DC-S",
      "product_quantity": "111 units",
      "reason_for_recall": "Delivery Catheter may  have sleeve liner separation that results in difficulty or inability  to  deploy heart valve device.",
      "recall_initiation_date": "20260731",
      "center_classification_date": "20261009",
      "report_date": "20261021",
      "code_info": "GTIN - 00850000898134/ Lot: DS-040826-003 DS-042326-003, DS-042726-006, DS-042826-005, DS-050426-007, DS-050626-002, DS-050626-006, DS-050626-009, DS-050726-005",
      "more_code_info": ""
    }
  ]
}