{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Grand Rapids",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91391",
      "recalling_firm": "SunMed Holdings, LLC",
      "address_1": "2710 Northridge Dr Nw Ste A",
      "address_2": "N/A",
      "postal_code": "49544-9112",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA.",
      "recall_number": "Z-1020-2023",
      "product_description": "AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA  Size          REF Number  0.0            60005  0.5            60055  1.0            60105  1.5            60155  2.0            60205  3.0            60305  4.0            60405",
      "product_quantity": "43,290 (Eaches)",
      "reason_for_recall": "There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through one of the channels, the clinician may use a smaller-diameter gastric catheter.",
      "recall_initiation_date": "20221222",
      "center_classification_date": "20230126",
      "report_date": "20230201",
      "code_info": "ALL LOTS   Size          REF            UDI/DI 0.0            60005        Each: 00814954020263 Box: 10814954020260 Case: 20814954020267 0.5            60055        Each: 00814954020270 Box: 10814954020277 Case: 20814954020274 1.0            60105        Each: 00814954020287 Box: 10814954021083 Case: 20814954020281 1.5            60155        Each: 00814954020294 Box: 10814954021090 Case: 20814954020298 2.0            60205        Each: 00814954020300 Box: 10814954021106 Case: 20814954020304 3.0            60305        Each: 00814954020317 Box: 10814954021113 Case: 20814954020311 4.0            60405        Each: 00814954020324 Box: 10814954021120 Case: 20814954020328",
      "more_code_info": ""
    }
  ]
}