{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Indianapolis",
      "address_1": "12263 Bridgewater Rd",
      "reason_for_recall": "BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled  as 60mm. The length callout on the label does not match the actual length of the sheath within the  packaging resulting in an improper fit as further explained below. This mislabeling was  discovered on 29-June-2012 during a clinical case.",
      "address_2": "",
      "product_quantity": "20 devices (4 boxes, 5 devices per box)",
      "code_info": "REF: NN-8011  - LOT: 80344-TD00214 (manufactured on 11-April-2012)",
      "center_classification_date": "20120813",
      "distribution_pattern": "Worldwide Distribution - USA including MI and Canada",
      "state": "IN",
      "product_description": "13.5 mm x 50 mm BrainPath Sheath    The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues.",
      "report_date": "20120822",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Nico Corp.",
      "recall_number": "Z-2200-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "62588",
      "termination_date": "20121107",
      "more_code_info": "",
      "recall_initiation_date": "20120717",
      "postal_code": "46256-9428",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}