{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Tucson",
      "state": "AZ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "73024",
      "recalling_firm": "Xeridiem Mediem Medical Devices Inc",
      "address_1": "4700 S Overland Dr",
      "address_2": "N/A",
      "postal_code": "85714-3430",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide distribution to MA only.",
      "recall_number": "Z-0938-2016",
      "product_description": "EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549340  (XMD P/N 70-0050-422)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.",
      "product_quantity": "40",
      "reason_for_recall": "A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.",
      "recall_initiation_date": "20151223",
      "center_classification_date": "20160225",
      "termination_date": "20161025",
      "report_date": "20160302",
      "code_info": "Part Number:  M00549340  (XMD P/N 70-0050-422)    Lot Number:  930141",
      "more_code_info": ""
    }
  ]
}