{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "216085",
      "product_res_number": "Z-0318-2026",
      "event_date_initiated": "2025-08-28",
      "event_date_posted": "2025-10-30",
      "recall_status": "Open, Classified",
      "res_event_number": "97607",
      "product_code": "QBJ",
      "k_numbers": [
        "K223931"
      ],
      "product_description": "Brand Name: Dexcom G6 Continuous Glucose Monitoring System\nProduct Name: Dexcom G6 and G6 Pro Android US CGM App\nModel/Catalog Number: SW11678\nSoftware Version: version 1.15.0\nProduct Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0\nComponent: Dexcom G6 Continuous Glucose Monitoring System",
      "code_info": "Lot Code: UDI:  SW11678 - 00386270000811",
      "firm_fei_number": "3004753838",
      "recalling_firm": "Dexcom, Inc.",
      "address_1": "6340 Sequence Dr",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92121-4356",
      "additional_info_contact": "Tim Peterson\n1-858-5294548",
      "reason_for_recall": "A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. This could result in the missed detection of a hyperglycemic or hypoglycemic event, protentional resulting in severe hyperglycemia, diabetic ketoacidosis (DKA), or hyperosmolar hyperglycemic state (HHS).",
      "root_cause_description": "Software Design Change",
      "action": "On 09/18/2025, the firm sent via in-app and email an \"URGENT: MEDICAL DEVICE CORRECTION NOTIFICATION\" communication informing customer that a bug has been identified within the G6 Android app version 1.15.0 that can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, or alerts.\n\nCustomers are instructed to:\nUpgrading from app version 1.15.0 is mandatory and they will not be able to use app version\n1.15.0 after October 6th, 2025. Update your app now to continue using the app:\n1. Open the App Store and search for the Dexcom G6 app.\n2. Install the latest Dexcom G6 app version.\n3. Open the Dexcom G6 app.\n\nFor questions or further assistance - contact Technical Support at 1-844-478-1600.  Technical Support is available 24 hours a day/7 days a week",
      "product_quantity": "333",
      "distribution_pattern": "This product was distributed throughout the US. G6 Android US v1.15.0 SW11678 G6 and G6 Pro Android app release has been halted <1% rollout after this issue was identified. Please see the attached consignee data for additional details.",
      "openfda": {
        "k_number": [
          "K201328",
          "K234133",
          "K231081",
          "K200876",
          "K223435",
          "K233537",
          "K243214",
          "K213919",
          "DEN170088",
          "K223931",
          "K222447",
          "K183206",
          "K253737",
          "K191450",
          "K221259",
          "K240902",
          "K261402",
          "K253710"
        ],
        "registration_number": [
          "3033394445",
          "2032098",
          "3002807314",
          "3009888344",
          "3004753838",
          "9710492",
          "3013820501",
          "1450743",
          "2030598",
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          "3008717264",
          "3012448339",
          "2024024",
          "3037326582",
          "3004105270",
          "2954323",
          "3038285067",
          "3010220595",
          "3003600763",
          "3027503105",
          "2029015",
          "3012302888",
          "3006537560",
          "3007421145",
          "3019807891",
          "3006371704",
          "3021611414",
          "3016904853",
          "3011120183",
          "3009901017",
          "3013435121"
        ],
        "fei_number": [
          "3033394445",
          "3002807314",
          "3009888344",
          "3004753838",
          "1000160458",
          "3003058448",
          "3013820501",
          "3003500908",
          "1450743",
          "1000518731",
          "3011536730",
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          "3012448339",
          "2024024",
          "3037326582",
          "3004105270",
          "3038285067",
          "3010220595",
          "3002803444",
          "3003600763",
          "3027503105",
          "3012302888",
          "3006537560",
          "3004173703",
          "3019807891",
          "3006371704",
          "3021611414",
          "3016904853",
          "3011120183",
          "3009901017",
          "3013435121"
        ],
        "device_name": "Integrated Continuous Glucose Monitoring System, Factory Calibrated",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1355",
        "device_class": "2"
      }
    }
  ]
}