{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "196622",
      "product_res_number": "Z-0458-2023",
      "event_date_initiated": "2022-10-21",
      "event_date_posted": "2022-12-08",
      "recall_status": "Open, Classified",
      "res_event_number": "91063",
      "product_code": "OWO",
      "product_description": "Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044",
      "code_info": "REF: 60044, UDI-DI: M927600440, Lot: 22041901",
      "firm_fei_number": "3008301917",
      "recalling_firm": "Intersect ENT, Inc.",
      "address_1": "1555 Adams Dr",
      "city": "Menlo Park",
      "state": "CA",
      "postal_code": "94025-1439",
      "additional_info_contact": "Brett Cromwell\n650-641-2115",
      "reason_for_recall": "Sinus Implant product label displays incorrect product information including: \"Straight Delivery System\", with incorrect reference number and UDI-DI.",
      "root_cause_description": "Error in labeling",
      "action": "On 10/21/22, recall notices from Medtronic/Intersect ENT were sent to customers who were asked to do the following: 1) Identify, quarantine, and return all unused affected products to  Medtronic.  2) Complete and return the customer confirmation form. 3) Distribute the recall notice to all others in your organization who should be aware, or to any organization where the potentially affected devices have been transferred. The following contact information was provided: rs.xentproductfeedback@medtronic.com and CustomerService@intersectent.com",
      "product_quantity": "611 units",
      "distribution_pattern": "US Nationwide distribution including in the states of NC, IL, KS, OR, WI, TX, FL, MN, WY, UT, NY, CA, NJ, OK, MD, HI, MT, TN, MO, IA, MA, AZ, GA, LA, ID, SC, WA, SD, ND, CO, NV.",
      "openfda": {
        "pma_number": [
          "P100044"
        ],
        "device_name": "Drug-Eluting Sinus Stent",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "3012102437",
          "3012448339",
          "3008301917",
          "2030598"
        ],
        "fei_number": [
          "3012102437",
          "3012448339",
          "1000518731",
          "3008301917"
        ]
      }
    }
  ]
}