{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "215935",
      "product_res_number": "Z-0019-2026",
      "event_date_initiated": "2025-08-29",
      "event_date_posted": "2025-10-02",
      "recall_status": "Open, Classified",
      "res_event_number": "97524",
      "product_code": "QTF",
      "product_description": "NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. \n\n\nThe NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. \n\nThis model is not cleared for marketing in the US.",
      "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",
      "firm_fei_number": "3005467144",
      "recalling_firm": "Northeast Scientific Inc.",
      "address_1": "2142 Thomaston Ave",
      "city": "Waterbury",
      "state": "CT",
      "postal_code": "06704-1013",
      "additional_info_contact": "Stephen Miller\n1-203-7562111 Ext. 112",
      "reason_for_recall": "Potential for breaches in the sterile barrier packaging, compromising sterility assurance.",
      "root_cause_description": "Process control",
      "action": "Northeast Scientific notified consignees via an \"URGENT: Medical Device Recall Notification\" letter dated 8/29/2025 and email.   Consignees were instructed to immediately discontinue use of affected products, quarantine and return any unused affected units, and complete and return the enclosed Recall Response Form, even if you no longer have any affected product. If product were further distributed, consignees were instructed to notify those customers immediately and ensure they also discontinue use and return the devices.\n\nNortheast Scientific will provide replacement product (if available) or credit for returned product.  In addition, Northeast Scientific has initiated an investigation and is implementing corrective actions to prevent recurrence.\n\nIf you have any questions or concerns, please reach out to your Northeast Scientific Sales Representative or contact us at Sales@nescientific.com or 203-756-2111.",
      "product_quantity": "173 units",
      "distribution_pattern": "US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.",
      "openfda": {
        "k_number": [
          "K220171"
        ],
        "device_name": "Reprocessed Atherectomy Catheter",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4875",
        "device_class": "2",
        "registration_number": [
          "3005467144"
        ],
        "fei_number": [
          "3005467144"
        ]
      }
    }
  ]
}