{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Fremont",
      "address_1": "41316 Christy St",
      "reason_for_recall": "Sterility failure found in one of the units in the lot.",
      "address_2": "",
      "product_quantity": "90 units",
      "code_info": "Lot 1711-08, Exp. 11/1/2019, UDI (01)00893872001059(17)191101(10)171108",
      "center_classification_date": "20181001",
      "distribution_pattern": "Distribution US nationwide and Switzerland.",
      "state": "CA",
      "product_description": "ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx.  The firm name on the label is Ellex iScience, Inc., Fremont, CA.  Used in ophthalmic surgery.",
      "report_date": "20181010",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Ellex iScience, Inc.",
      "recall_number": "Z-0011-2019",
      "initial_firm_notification": "Telephone",
      "product_type": "Devices",
      "event_id": "80569",
      "termination_date": "20181002",
      "more_code_info": "",
      "recall_initiation_date": "20180111",
      "postal_code": "94538-3115",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}