{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "156975",
      "product_res_number": "Z-0528-2018",
      "event_date_initiated": "2017-06-05",
      "event_date_created": "2018-02-05",
      "recall_status": "Terminated",
      "event_date_terminated": "2018-09-11",
      "res_event_number": "77631",
      "product_code": "NEY",
      "k_numbers": [
        "K094021"
      ],
      "product_description": "Accu2i pMTA  Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (UPN) H7879006020, STERILE --- This is only for use with a Sulis V Generator, REF 806-10.\n\nProduct Usage:\nThe Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.",
      "code_info": "Lots: 15310413, 15320415, 15340429, 15350431, 15360432, 15370435, 15380440, 15390444, 15400450, 15430456, 15440460, 15460467, 15470469, 15480471, 15490477, 15500481, 15520484, 16010489, 16050495, 16070500, 16080503, 16090506, 16100509, 16120513, 16150521, 16160523, 16170529, 16190534, 16230548, 16240551, 16250557, 16270563, 16300569, 16310571, 16320575, 16330577, 16350582, 16350586, 16370591, 16390596, 16410602, 16430610, 16440613, 16450618, 16460619, 16500636, 16510644, 17020651, 17040658, 17050660, 17060663, 17070668, 17100674, 17110678,  17130685.",
      "firm_fei_number": "1319211",
      "recalling_firm": "Angiodynamics, Inc.",
      "address_1": "603 Queensbury Ave",
      "city": "Queensbury",
      "state": "NY",
      "postal_code": "12804-7619",
      "additional_info_contact": "Warren Nighan\n508-658-7940",
      "reason_for_recall": "The firm is recalling product that has the potential to not function during use.   The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.",
      "root_cause_description": "Under Investigation by firm",
      "action": "URGENT VOLUNTARY MEDICAL DEVICE RECALL Letters and Response Forms (dated June 5, 2107) were sent to consignees via FedEx on June 5, 2017.  The letter identified the affected product, problem and actions to be taken.",
      "product_quantity": "14,353 units in total",
      "distribution_pattern": "Worldwide distribution - US Nationwide",
      "openfda": {
        "k_number": [
          "K223272",
          "K250718",
          "K200081",
          "K113237",
          "K100744",
          "K241825",
          "K240784",
          "K171358",
          "K133821",
          "K122762",
          "K122217",
          "K162449",
          "K182250",
          "K231738",
          "K041340",
          "K180396",
          "K130399",
          "K252632",
          "K240480",
          "K083537",
          "K223581",
          "K072687",
          "K213067",
          "K221883",
          "K061865",
          "K220472",
          "K181941",
          "K253771",
          "K143203",
          "K083157",
          "K233140",
          "K160141",
          "K141785",
          "K200298",
          "K241827",
          "K200003",
          "K193232",
          "K003978",
          "K072870",
          "K070023",
          "K232240",
          "K070356",
          "K052919",
          "K082565",
          "K082819",
          "K081042",
          "K192406",
          "K100786",
          "K183153",
          "K163118",
          "K173756",
          "K233838",
          "K094021",
          "K163105",
          "K013946",
          "K240518",
          "K200061",
          "K232241",
          "K053535",
          "K160936",
          "K201265",
          "K201262",
          "K203303",
          "K011676",
          "K221672",
          "K222388",
          "K200796",
          "K223138"
        ],
        "registration_number": [
          "",
          "3026612481",
          "3015152398",
          "3008361498",
          "1526611",
          "3001592626",
          "1721686",
          "3018094310",
          "3010933564",
          "3008082710",
          "1000523114",
          "3027728071",
          "3007007790",
          "1717344",
          "3004962788",
          "3030234858",
          "2246552",
          "3008132398",
          "8010312",
          "1721676",
          "3005382058",
          "1928237",
          "3045005759",
          "3016688836",
          "3017892510",
          "3013875526",
          "3006451981",
          "3014925413",
          "3020309549",
          "3013440400",
          "3015540957",
          "1724474",
          "3039443404",
          "1721983",
          "3004636440",
          "3008262715",
          "1319211",
          "3008769756",
          "3006638824",
          "3022977243"
        ],
        "fei_number": [
          "",
          "3026612481",
          "3015152398",
          "3008361498",
          "1526611",
          "3001592626",
          "1721686",
          "3018094310",
          "3010933564",
          "3008082710",
          "1000523114",
          "3027728071",
          "3007007790",
          "1717344",
          "3004962788",
          "3008237808",
          "3030234858",
          "2246552",
          "1721676",
          "3005382058",
          "3003094851",
          "1928237",
          "3002807091",
          "3045005759",
          "3016688836",
          "3017892510",
          "3013875526",
          "3006451981",
          "3014925413",
          "3020309549",
          "3013440400",
          "3015540957",
          "3039443404",
          "1000064530",
          "3004636440",
          "3008262715",
          "1319211",
          "3008769756",
          "3006638824",
          "3022977243"
        ],
        "device_name": "System, Ablation, Microwave And Accessories",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4400",
        "device_class": "2"
      }
    }
  ]
}