{
  "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": "2026-10-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "211988",
      "product_res_number": "Z-1202-2025",
      "event_date_initiated": "2025-01-27",
      "event_date_posted": "2025-02-20",
      "recall_status": "Open, Classified",
      "res_event_number": "96091",
      "product_code": "QBJ",
      "k_numbers": [
        "K223931"
      ],
      "product_description": "Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001",
      "code_info": "All Serial Numbers/UDI: 00386270000583",
      "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": "Dexcom Technical Support\n844-607-8398",
      "reason_for_recall": "Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose\nalarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net\nerror occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a\nsubsequent alarm/alert is triggered. At that time, the initial alarm/alert is delivered, but not the second one.\nAlarm/alerts will continue to be delayed and be one alarm/alert behind, causing delayed alarm/alerts until the\nreceiver is reset. This condition could result in the missed detection of a hyperglycemic or hypoglycemic event.\nSecond, a single EGV reading may be delayed for 5 minutes after the initial .net operating system error. If the\nuser receives a single EGV reading delayed by 5 minutes, the delay is not expected to cause user harm.",
      "root_cause_description": "Software design",
      "action": "On January 27, 2025, Dexcom issued a \"Urgent: Medical Device Correction to affected consignees via E-Mail. Dexcom asked consignees to take the following actions: \n\nIf available, use the G6 App as primary display device to receive glucose readings and alerts. The G6 transmitter allows simultaneous communication with an iOS or Android device as well as a receiver (see letter for additional details). \n\nIf using an affected G6 Receiver, check CGM glucose values and glucose trend regularly as CGM glucose values and glucose trend graph information continue to be displayed\n\nIf you believe you may be experiencing the missed or delayed alarm/alerts issue, the issue can be corrected by shutting down the receiver and then turning it back on.\n\nPlease navigate to the following webpage: https://www.dexcom.com/g6-receiver-update\n\nPlease read the information provided on the webpage and any recommended actions regarding a software update for your receiver to permanently resolve this issue.",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of OH, TX, PA, MN, SC, NH, FL, CA, NJ, PR, GA and the countries of Austria, Belgium, Canada, Switzerland, Germany, Spain, France, Ireland, Japan, Netherlands, Slovenia, United Kingdom,  Australia, Czech Republic, Denmark, Finland, France, Hong Kong, Israel, Italy, Korea, Kuwait, New Zealand, Norway, Oman, Poland, Qatar, Saudi Arabia, Singapore, Slovakia, South Africa, Sweden, Turkey, United Arab Emirates.",
      "openfda": {
        "k_number": [
          "K221259",
          "K253737",
          "DEN170088",
          "K191450",
          "K223931",
          "K231081",
          "K234133",
          "K201328",
          "K213919",
          "K233537",
          "K183206",
          "K240902",
          "K222447",
          "K253710",
          "K200876",
          "K261402",
          "K223435",
          "K243214"
        ],
        "registration_number": [
          "3013820501",
          "2024024",
          "2032098",
          "3009888344",
          "3009901017",
          "9710492",
          "3007421145",
          "3004111573",
          "3004753838",
          "3021611414",
          "3011120183",
          "2029015",
          "3002807090",
          "3002807314",
          "2954323",
          "3033394445",
          "1450743",
          "3027503105",
          "3006371704",
          "3012448339",
          "3038285067",
          "3010220595",
          "3037326582",
          "3013435121",
          "3003600763",
          "2030598",
          "3012302888",
          "3016904853",
          "3008717264",
          "3006537560",
          "3004105270",
          "3011536730",
          "3019807891"
        ],
        "fei_number": [
          "3013820501",
          "2024024",
          "3009888344",
          "3009901017",
          "3004111573",
          "3004753838",
          "3021611414",
          "3011120183",
          "1000518731",
          "3002807314",
          "3006003617",
          "3033394445",
          "1450743",
          "3027503105",
          "3004173703",
          "3003058448",
          "3006371704",
          "3012448339",
          "3038285067",
          "3010220595",
          "3002803444",
          "3037326582",
          "3013435121",
          "3003600763",
          "3012302888",
          "3016904853",
          "3008717264",
          "3006537560",
          "3004105270",
          "1000160458",
          "3011536730",
          "3019807891",
          "3003500908"
        ],
        "device_name": "Integrated Continuous Glucose Monitoring System, Factory Calibrated",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1355",
        "device_class": "2"
      }
    }
  ]
}