{
  "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": [
    {
      "status": "Terminated",
      "city": "Fremont",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "65654",
      "recalling_firm": "Stryker Neurovascular",
      "address_1": "47900 Bayside Pkwy",
      "address_2": "N/A",
      "postal_code": "94538-6515",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "International Distribution including Austria, China, and Germany.",
      "recall_number": "Z-1808-2013",
      "product_description": "Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product Number: M003450200, Product is manufactured by Boston Scientific Corporation, Fremont, CA and distributed by Stryker Neurovascular, Fremont, CA     The Neuroform Microdelivery Stent System is intended for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of greater than equal to 2 mm and greater than equal to 4.5 mm that are not amenable to treatment with surgical clipping.",
      "product_quantity": "23 units",
      "reason_for_recall": "The device is labeled incorrectly, in that, the device Model Number on the outer carton and inner pouch labels did not match, although both referenced the same lot number. The Model Number on the outer box states UPN M003E345020 (4.5mm x 20 mm Neuroform 3 Stent) while the pouch label states UPN M003E3450300 (4.5mm x 30 mm Neuroform 3 Stent).",
      "recall_initiation_date": "20130624",
      "center_classification_date": "20130725",
      "termination_date": "20130930",
      "report_date": "20130731",
      "code_info": "Code:  M003450200, Lot 15391019, Expiration Date:  2015-07",
      "more_code_info": ""
    }
  ]
}