{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "189276",
      "product_res_number": "Z-0073-2022",
      "event_date_initiated": "2020-04-24",
      "event_date_created": "2021-10-07",
      "recall_status": "Terminated",
      "event_date_terminated": "2022-09-20",
      "res_event_number": "88679",
      "product_code": "OAB",
      "k_numbers": [
        "K150089"
      ],
      "product_description": "AngioDynamics NanoKnife Disposable Single Electrode\nProbes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103",
      "code_info": "lot 5577754",
      "firm_fei_number": "1319211",
      "recalling_firm": "Angiodynamics, Inc.",
      "address_1": "603 Queensbury Ave",
      "city": "Queensbury",
      "state": "NY",
      "postal_code": "12804-7619",
      "additional_info_contact": "Saleem Cheeks\n518-798-1174",
      "reason_for_recall": "Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator.",
      "root_cause_description": "Software Manufacturing/Software Deployment",
      "action": "On April 24, 2020, the firm distributed recall notifications to their consignees, who were all international (non-US). Customers were advised to stop using the recalled product, remove it from inventory, and segregate in a secure location for return. The firm provided further instructions for the return of the product.",
      "product_quantity": "37",
      "distribution_pattern": "Internationally distribution to the countries of Australia, Germany, Denmark, France, and Thailand.",
      "openfda": {
        "k_number": [
          "K253846",
          "K080376",
          "K150089",
          "K222001",
          "K060054",
          "K242687",
          "K102329",
          "K080202",
          "K253198",
          "K240297",
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          "K212871",
          "K253826",
          "K233884",
          "K183385"
        ],
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          "1319211",
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        ],
        "device_name": "Low Energy Direct Current Thermal Ablation System",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4400",
        "device_class": "2"
      }
    }
  ]
}