{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "199181",
      "product_res_number": "Z-1381-2023",
      "event_date_initiated": "2023-03-02",
      "event_date_posted": "2023-04-12",
      "recall_status": "Open, Classified",
      "res_event_number": "91909",
      "product_code": "OAB",
      "k_numbers": [
        "K183385"
      ],
      "product_description": "NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue.\nCatalog Number: 20400111\nUPN: H787204001110",
      "code_info": "UDI-DI: 15051684029643\nLot Number: 5762110",
      "firm_fei_number": "1319211",
      "recalling_firm": "Angiodynamics, Inc.",
      "address_1": "603 Queensbury Ave",
      "city": "Queensbury",
      "state": "NY",
      "postal_code": "12804-7619",
      "additional_info_contact": "SAME\n518-798-1215",
      "reason_for_recall": "Not programmed in accordance with specification. The programming affects the RFID function and does not\nallow the NanoKnife probes to be recognized by the NanoKnife generator resulting in a delay in procedure",
      "root_cause_description": "Under Investigation by firm",
      "action": "AngioDynamics issued Urgent Medical Device Recall Letter on March 2, 2023\nvia Federal Express. Letter states reason for recall health risk and action to take:\nIMMEDIATELY\nStop using the product subject to recall.\n Remove any affected (recalled) product from your inventory (whether in labs, Central\nSupply, Shipping and Receiving or ANY other location.\nSegregate this product in a secure location for return to AngioDynamics, Inc.\n Forward a copy of this recall notification to all sites to which you have distributed affected product.\n2. ComplFx Reply Verification Tracking Form:\nAttn: NK Probe 5-Pack Recall Coordinator\nFax number 1-855-273-0519\n3. Package and Return the Recalled Product.\nPackage any product that is being returned in an appropriate shipping box.\nWrite the RMA number on the RMA/Address label (provided on the Recall Verification Tracking Form) and affix the label to the outside of the shipping box.\nSeal the box and return to:\nAngioDynamics, Inc.\n24 Native Drive\nQueensbury, NY 12804\nAttn: NK Probe 5-Pack Recall Coordinator",
      "product_quantity": "10 boxes( 5 probes/box)",
      "distribution_pattern": "US Nationwide Distribution:  CA,CO, FL, IA, NY, OH",
      "openfda": {
        "k_number": [
          "K212871",
          "K060054",
          "K102329",
          "K233884",
          "K253198",
          "K183385",
          "K240297",
          "K253826",
          "K150089",
          "K080376",
          "K222001",
          "K080202",
          "K242687",
          "K253846",
          "K240376"
        ],
        "registration_number": [
          "3017892510",
          "1319211",
          "1721676",
          "3008849319",
          "2244478",
          "9611854",
          "3015540957",
          "3017448139",
          "3017185164",
          "3021023752",
          "3016020790",
          "2031093",
          "3043527620",
          "1000523114",
          "3040004547"
        ],
        "fei_number": [
          "3017892510",
          "1319211",
          "1721676",
          "3008849319",
          "3001236549",
          "3015540957",
          "3017448139",
          "3017185164",
          "3021023752",
          "1000136269",
          "3002807258",
          "3016020790",
          "3043527620",
          "1000523114",
          "3040004547"
        ],
        "device_name": "Low Energy Direct Current Thermal Ablation System",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4400",
        "device_class": "2"
      }
    }
  ]
}