{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Jacksonville",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63008",
      "recalling_firm": "Medtronic Xomed, Inc.",
      "address_1": "6743 Southpoint Dr N",
      "address_2": "N/A",
      "postal_code": "32216-6218",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution: USA (nationwide) and countries of:  Australia, Austria, Belgium, Canada, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Iran, Ireland, Israel, Italy, Japan, Lebanon, Libya, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Saudia Arabia, Singapore, Slovak, Spain, SRI Lanka, Sweden, Turkey, United Arab Emirates, and United Kingdom.",
      "recall_number": "Z-2343-2012",
      "product_description": "Interfaces subject to recall:    Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro).    LABELING:    Box Label:  REF 8253410 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA***Rx Only***Lot***SN:***\"    Top of unit is labeled in part:  \"***NIM-Response 3.0***Medtronic***\"    Bottom/Underside of unit is labeled in part:  \"***5X20mm FA.L., 32mA. 250VAC***REF***MEDTRONIC XOMED INC. JACKSONVILLE, FL USA***\"    Cord is labeled in part:  \"***Ref.***Mfg Date***Sn***\"    The NIM 3.0 Patient Interfaces [REF #'s 8253210 (Pulse), 8253200 (Response), 8253410 (Neuro)] is an EMG Nerve Integrity Monitor intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots.",
      "product_quantity": "53",
      "reason_for_recall": "In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode).  When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu",
      "recall_initiation_date": "20100927",
      "center_classification_date": "20120910",
      "termination_date": "20131126",
      "report_date": "20120919",
      "code_info": "8253410 (Neuro). All Serial Numbers."
    }
  ]
}