{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "221248",
      "product_res_number": "Z-2855-2026",
      "event_date_initiated": "2026-03-23",
      "event_date_posted": "2026-07-31",
      "recall_status": "Open, Classified",
      "res_event_number": "99307",
      "product_code": "QGT",
      "k_numbers": [
        "K250405"
      ],
      "product_description": "Nerivio Infinity. Model/Catalog Number: FGD000100. \nSoftware Version: FW Version 4.1.2.0, App version 7.28.0.11",
      "code_info": "Model/Catalog Number: FGD000100. UDI: 01072900175781181125120221NI2544-0300673\nSoftware Version: FW Version 4.1.2.0, App version 7.28.0.11\n\nGTIN: 7290017578118. \nSerial Number: NI2544-0300673.",
      "firm_fei_number": "3015379717",
      "recalling_firm": "THERANICA BIOELECTRONICS LTD",
      "address_1": "45 poleg industrial park",
      "city": "Netanya",
      "state": "Ha-Melakha",
      "country": "Israel",
      "reason_for_recall": "Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.",
      "root_cause_description": "Component design/selection",
      "action": "Firm issued a stop ship of product from distributors starting March 22, 2026 after learning of the reported event. These devices were released from hold on 4/30/2026, after the device firmware update was released on 4/19/26.\n\nStarting May 13, 2026, customers received in-app messaging which ensure that all affected users receive instructions regarding the required corrective action. \n\nUsers were prompted to perform a software update affecting both the mobile application used to control the device and the device firmware. The firmware update permanently disables the device upon detection of an overheating event. The software update provides an enhanced warning mechanism if it detects a device malfunction.",
      "product_quantity": "11,886 units",
      "distribution_pattern": "The product's entry point to the US is a 3PL warehouse from which it is being shipped to DME distributors or specialty pharmacy who perform the shipment to the end-user",
      "openfda": {
        "k_number": [
          "K250405",
          "K201824",
          "K241756",
          "K232152",
          "K203181",
          "DEN180059",
          "K223169"
        ],
        "device_name": "Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.5899",
        "device_class": "2",
        "registration_number": [
          "3035454575",
          "3015549449",
          "3015379717"
        ],
        "fei_number": [
          "3035454575",
          "3015549449",
          "3015379717"
        ]
      }
    }
  ]
}