{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "220369",
      "product_res_number": "Z-2515-2026",
      "event_date_initiated": "2026-05-11",
      "event_date_posted": "2026-06-18",
      "recall_status": "Open, Classified",
      "res_event_number": "98990",
      "product_code": "MNQ",
      "pma_numbers": [
        "P130008"
      ],
      "product_description": "Brand Name: Inspire Medical Systems, Inc.\r\nProduct Name: Inspire Respiratory Sensing Lead\r\nModel/Catalog Number: 4340\r\nSoftware Version: N/A\r\nProduct Description: The Inspire Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG).\r\nComponent: N/A",
      "code_info": "Lot Code: Model No 4340 (USA only lead); UDI-DI [4340] 10855728005946; Inspire part number [4340] 900-014-003;  serial numbers T18806, T45012, T45017, T49002, T67098, T67152, T69541, T69542, T69553, T69558, T69562\n\nModel No 4340 (Global lead); UDI-DI [4340] 10810098650301; Inspire part number [4340] 900-014-005; serial numbers T91485, T91486, T91491, T91495, T91513, T91520, T91521, T91527, T91533, T91537, T91540, T91545, T96165, T96168, T96192, T96193, T96195, T96225, T96237, T98118, T98126, T98136, T98137, T98138, T98141, T98143, T98145, T98150, T98153, T98156, T98163, T98165, T98176, T98177, T98178, T98181, T98183, T98190, T96217",
      "firm_fei_number": "3007666314",
      "recalling_firm": "Inspire Medical Systems Inc.",
      "address_1": "5500 Wayzata Blvd Ste 1600 5500 Wayzata Blvd",
      "address_2": "Ste 1600",
      "city": "Golden Valley",
      "state": "MN",
      "postal_code": "55416-1237",
      "additional_info_contact": "763-205-7974",
      "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.",
      "root_cause_description": "Process control",
      "action": "Firm began notifying consignees on May 11, 2026. Letters were titled \"URGENT Medical Device Correction.\"\n\nThe firm requests consignees' assistance in removing affected product from clinical inventory and returning them to Inspire.",
      "product_quantity": "50 impacted units",
      "distribution_pattern": "Worldwide  distribution - US Nationwide and the country of Hong Kong.",
      "openfda": {
        "pma_number": [
          "P130008",
          "P250013",
          "P240024"
        ],
        "device_name": "Stimulator, Hypoglossal Nerve, Implanted, Apnea",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "2183613",
          "3010376846",
          "3030384402",
          "3030499299",
          "2183787",
          "3017191859",
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          "3003857828",
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          "3008851924",
          "3007666314",
          "3036471728",
          "2183744"
        ],
        "fei_number": [
          "2183613",
          "3010376846",
          "3030384402",
          "3030499299",
          "2183787",
          "3017191859",
          "1047843",
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          "3008851924",
          "3007666314",
          "3036471728",
          "2183744"
        ]
      }
    }
  ]
}