{
  "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": "191240",
      "product_res_number": "Z-0540-2022",
      "event_date_initiated": "2021-12-09",
      "event_date_created": "2022-01-28",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-09-08",
      "res_event_number": "89306",
      "product_code": "GZL",
      "k_numbers": [
        "K170959"
      ],
      "product_description": "The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.",
      "code_info": "All lots\n\nUDI:03664539000114",
      "firm_fei_number": "3014527920",
      "recalling_firm": "DIXI MEDICAL USA",
      "address_1": "11910 Fox Ridge Dr",
      "city": "Plymouth",
      "state": "MI",
      "postal_code": "48170-2877",
      "reason_for_recall": "Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag",
      "root_cause_description": "Under Investigation by firm",
      "action": "Dixi Medical issued Urgent Medical Device Letter on 12/9/21. Letter states reason for recall, health risk and action to take:\n1.\tExamine your inventory for the affected product. Any available stock must be quarantined immediately and placed in a secure location to prevent further usage.\n2.\tPlease use the response form to record and return the stock back to the manufacturer.\n3.\tThe returned stock will be replaced with compliant products.\n4.\tPlease complete and return the attached Customer Response Form to Ann Cirner, ann.cirner@diximedus.com (248)845-3494, even if you do not have affected product on hand.\n5.\tPlease forward this information to all your staff that may use the MICRODEEP during a SEEG procedure in your healthcare facility.\n6.\tIf you have further distributed the product, please forward this notification to any downstream accounts.\nThe removal and return of affected products will be carried out by the hospital staff. Your assistance is appreciated and necessary to prevent a potential patient harm. \n\nIf you have any questions, call Ann Cirner, ann.cirner@diximedus.com (248)845-3494",
      "product_quantity": "345 units",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
        "k_number": [
          "K211367",
          "K222404",
          "K970418",
          "K891920",
          "K946018",
          "K191739",
          "K082404",
          "K802151",
          "K981015",
          "K223269",
          "K012850",
          "K981820",
          "K993622",
          "K120098",
          "K181544",
          "K123796",
          "K220553",
          "K041409",
          "K991522",
          "K250363",
          "K970943",
          "K201678",
          "K991077",
          "K861031",
          "K170959",
          "K202087",
          "K250601",
          "K172042",
          "K802152",
          "K902976",
          "K033173",
          "K071697",
          "K041604",
          "K944061",
          "K052527",
          "K042208",
          "K213170",
          "K051830",
          "K070272",
          "K140680",
          "K163355",
          "K183123",
          "K053358",
          "K071364",
          "K973454",
          "K253970",
          "K222706",
          "K033730",
          "K990788",
          "K964644",
          "K042384",
          "K171581",
          "K151790",
          "K802249",
          "K152547",
          "K162459",
          "K110010",
          "K223276"
        ],
        "registration_number": [
          "",
          "2183456",
          "3024996452",
          "3006258094",
          "8043398",
          "3002250546",
          "3007323246",
          "1721676",
          "3007636029",
          "2183744",
          "1319639",
          "3008773490",
          "1064858",
          "3008102042",
          "3009766315",
          "3005581270",
          "3008534770",
          "3010383847",
          "3002808227",
          "3016438686",
          "9615126",
          "2528981",
          "2182979",
          "3000203391"
        ],
        "fei_number": [
          "",
          "1000138054",
          "2183456",
          "3002924544",
          "3024996452",
          "3001610756",
          "3006258094",
          "3008397795",
          "3003630373",
          "3002250546",
          "3007323246",
          "1721676",
          "3007636029",
          "2183744",
          "3008773490",
          "3009766315",
          "3005581270",
          "3008534770",
          "3010383847",
          "3002808227",
          "3016438686",
          "2528981",
          "2182979",
          "3000203391"
        ],
        "device_name": "Electrode, Depth",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.1330",
        "device_class": "2"
      }
    }
  ]
}