{
  "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": 1
    }
  },
  "results": [
    {
      "cfres_id": "213398",
      "product_res_number": "Z-1906-2025",
      "event_date_initiated": "2025-05-05",
      "event_date_posted": "2025-06-04",
      "recall_status": "Open, Classified",
      "res_event_number": "96684",
      "product_code": "QBJ",
      "k_numbers": [
        "K231081"
      ],
      "product_description": "Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system",
      "code_info": "Software version  2.7.0/ UDI: 00386270001863",
      "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": "Chuck BOykin\n858-200-0200",
      "reason_for_recall": "A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are not being updated\nand that glucose alerts will not trigger, there is potential for the missed detection of a hyperglycemic or hypoglycemic event or a treatment decision made based off incorrect data.  There is no impact to transmitter communication with concurrently connected displays. A\nconcurrently connected receiver, Apple Watch, and/or insulin pump will continue to receive EGVs directly from the transmitter when the app is in the problematic state. There is no impact to Automated Insulin Dosing (AID) therapy as the AID system continues to receive EGVs directly from the transmitter.",
      "root_cause_description": "Software design",
      "action": "On May 05, 2025, Dexcom issued a \"Urgent Warning\" Recall notification to affected consignees via application update.  Dexcom asked consignees to take the following actions: \n\n1. Upgrading from app version 2.7 is mandatory and app version 2.7 is no longer available for use.\n\n2. If you need assistance, contact Technical Support. Local Tech Support contact information is available at Dexcom.com\n\nPlease note that US customers should utilize one of the following options for support.\n\"\tPhone - 1-844-478-1600\n\"\tCall Back request   Call Back Request Form\n\"\tWeb Form - https://dexcom.custhelp.com/app/webform\n\"\tLive chat - https://dexcom.custhelp.com/app/chat/chat_avail\n\nIf you have any questions, call 858-200-0200 or email: Charles.boykin@dexcom.com.",
      "product_quantity": "61,355 users",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: United Arab Emirates (AE), Austria (AT),\tAustralia (AU), Belgium (BE), Bahrain (BH), Canada (CA),\tSwitzerland (CH), Czech Republic (CZ), Germany (DE), Denmark (DK), Spain (ES), Finland (FI), France (FR), United Kingdom (GB), Hong Kong (HK), Ireland (IE), Israel (IL), Iceland (IS), Italy (IT), Jordan (JO), Korea, Repulic (KR), Kuwait (KW), Lebanon (LB), Lithuania (LT), Luxemburg (LU), Malta (MT), Netherlands (NL), Norway (NO), New Zealand (NZ), Oman (OM), Poland (PL), Portugal (PT), Qatar (QA), Saudi Arabia (SA), Sweden (SE), Slovenia (SI), Slovakia (SK), Turkey (TR) and South Africa (ZA).",
      "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",
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          "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"
      }
    }
  ]
}