{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "San Diego",
      "state": "CA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97262",
      "recalling_firm": "Dexcom, Inc.",
      "address_1": "6340 Sequence Dr",
      "address_2": "N/A",
      "postal_code": "92121-4356",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "SW12299 G7 Android CGM App   Worldwide Distribution - US Nationwide and the countries of Andorra, United Arab Emirates, Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, Iceland, Italy, Jordan, Japan, South Korea, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Qatar, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa   SW12300 G7 iOS CGM App   Worldwide Distribution - US Nationwide and the countries of United Arab Emirates, Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Iceland, Italy, Jordan, Japan, South Korea, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Qatar, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa   SW14245 Dexcom ONE+ Android Mobile App   OUS worldwide distribution to the countries of Andorra, Australia, Belgium, Bulgaria, Estonia, Spain, France, United Kingdom, Greece, Croatia, Ireland, Israel, Italy, Lithuania, Latvia, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, Sweden  SW14244 D1G7 iOS Mobile App   OUS worldwide distribution to the countries of Andorra, Australia, Belgium, Bulgaria, Estonia, Spain, France, United Kingdom, Greece, Croatia, Ireland, Italy, Lithuania, Latvia, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, Sweden",
      "recall_number": "Z-2446-2025",
      "product_description": "Brand Name: Dexcom G7 Continuous Glucose Monitoring System  Product Name: Dexcom G7 CGM Android App  Model/Catalog Number: SW12299  Software Version: version 2.8.0 and earlier  Product Description: Dexcom G7 CGM Android App SW12299  Component: Dexcom G7 Continuous Glucose Monitoring System",
      "product_quantity": "532821",
      "reason_for_recall": "The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the \u001cApp\u001d. The affected App does not provide an expected \"Sensor Failed\" alert when the transmitter sends a \"transmitterFailed\" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the \u001cStart Sensor\u001d screen or \u001cNo active sensor\u001d message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment.",
      "recall_initiation_date": "20250724",
      "center_classification_date": "20250904",
      "report_date": "20250910",
      "code_info": "Lot Code: UDI:  SW12299 - 00386270001870"
    }
  ]
}