{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "74770",
      "product_res_number": "Z-0498-2009",
      "event_date_initiated": "2008-10-20",
      "event_date_posted": "2008-12-18",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-05-02",
      "res_event_number": "50103",
      "product_code": "GZL",
      "k_numbers": [
        "K991522"
      ],
      "product_description": "FC4000 MicroTargeting Electrode Kit 5x \nFor use with Nexframe and Nexdrive\nDistributed by Medtronic Inc., Minneapolis, MN\nREF: FCH 4000 (5 Prefilled single use kits -5 packages and 2 electrodes each)\n\nIntended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain.",
      "code_info": "Lot number: 866051",
      "firm_fei_number": "3002250546",
      "recalling_firm": "FHC, Inc.",
      "address_1": "1201 Main Street",
      "city": "Bowdoinham",
      "state": "ME",
      "postal_code": "04008",
      "additional_info_contact": "SAME\n207-666-8190",
      "reason_for_recall": "Mislabeled: May contain an electrode longer than labeled size",
      "root_cause_description": "Pending",
      "action": "FHC notified customers via an Urgent: Medical Device Recall letter dated 10/20/08 advising users to remove the recalled electrodes from inventory and set the product aside for inspection by your FHC representative.  Customers were asked to document their actions by completing the enclosed form and faxing it back to FHC at 207-666-8539.",
      "product_quantity": "3 Kits  (30 electrodes-10 electrodes/kit)",
      "distribution_pattern": "Nationwide Distribution --- including states of CA, CO, FL, LA, NM, PA, TN, and PR.",
      "openfda": {
        "k_number": [
          "K802152",
          "K152547",
          "K202087",
          "K211367",
          "K213170",
          "K220553",
          "K253970",
          "K990788",
          "K973454",
          "K052527",
          "K970418",
          "K991522",
          "K191739",
          "K970943",
          "K981015",
          "K151790",
          "K946018",
          "K223269",
          "K042384",
          "K222404",
          "K250601",
          "K802151",
          "K033730",
          "K041409",
          "K120098",
          "K053358",
          "K162459",
          "K223276",
          "K172042",
          "K163355",
          "K082404",
          "K201678",
          "K250363",
          "K170959",
          "K071697",
          "K033173",
          "K181544",
          "K183123",
          "K944061",
          "K042208",
          "K802249",
          "K123796",
          "K902976",
          "K861031",
          "K041604",
          "K991077",
          "K070272",
          "K981820",
          "K891920",
          "K171581",
          "K964644",
          "K110010",
          "K222706",
          "K012850",
          "K071364",
          "K993622",
          "K051830",
          "K140680"
        ],
        "device_name": "Electrode, Depth",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.1330",
        "device_class": "2",
        "registration_number": [
          "",
          "3002250546",
          "3009766315",
          "1064858",
          "1721676",
          "8043398",
          "3005581270",
          "3008773490",
          "2183456",
          "1319639",
          "3024996452",
          "3010383847",
          "2182979",
          "2528981",
          "2183744",
          "3000203391",
          "3008534770",
          "3008102042",
          "9615126",
          "3006258094",
          "3007323246",
          "3002808227",
          "3007636029",
          "3016438686"
        ],
        "fei_number": [
          "",
          "3002250546",
          "3009766315",
          "1721676",
          "3008397795",
          "1000138054",
          "3005581270",
          "3008773490",
          "2183456",
          "3002924544",
          "3024996452",
          "3010383847",
          "2182979",
          "2528981",
          "3003630373",
          "3001610756",
          "2183744",
          "3000203391",
          "3008534770",
          "3006258094",
          "3007323246",
          "3002808227",
          "3007636029",
          "3016438686"
        ]
      }
    }
  ]
}