{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Waterbury",
      "state": "CT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97524",
      "recalling_firm": "Northeast Scientific Inc.",
      "address_1": "2142 Thomaston Ave",
      "address_2": "N/A",
      "postal_code": "06704-1013",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.",
      "recall_number": "Z-0019-2026",
      "product_description": "NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151.       The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.     This model is not cleared for marketing in the US.",
      "product_quantity": "173 units",
      "reason_for_recall": "Potential for breaches in the sterile barrier packaging, compromising sterility assurance.",
      "recall_initiation_date": "20250829",
      "center_classification_date": "20251002",
      "report_date": "20251008",
      "code_info": "Model No R-414-151; UDI-DI 00850044399116; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026"
    }
  ]
}