{
  "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": "2026-06-24",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Golden Valley",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "98990",
      "recalling_firm": "Inspire Medical Systems Inc.",
      "address_1": "5500 Wayzata Blvd Ste 1600",
      "address_2": "",
      "postal_code": "55416-1237",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide  distribution - US Nationwide and the country of Hong Kong.",
      "recall_number": "Z-2516-2026",
      "product_description": "Brand Name: Inspire Medical Systems, Inc.  Product Name: Inspire stimulation Lead  Model/Catalog Number: 4063  Product Description: The Inspire¿ Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the   implantable pulse generator (IPG).  Component: N/A",
      "product_quantity": "10 impacted units",
      "reason_for_recall": "Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.",
      "recall_initiation_date": "20260511",
      "center_classification_date": "20260618",
      "report_date": "20260624",
      "code_info": "Lot Code: Model 4063 (USA only lead); UDI-DI [4063] 10855728005793; Inspire part number [4063] 900-013-001; serial numbers D53393, D61104  Model 4063 (Global lead); UDI-DI [4063] 10810098650295, Inspire part number [4063] 900-013-003; serial numbers D89539, D89540, D89543, D89559, D89563, D89564, D89577, D8959",
      "more_code_info": ""
    }
  ]
}