{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 5 } }, "results": [ { "cfres_id": "215005", "product_res_number": "Z-2446-2025", "event_date_initiated": "2025-07-24", "event_date_posted": "2025-09-04", "recall_status": "Open, Classified", "res_event_number": "97262", "product_code": "QBJ", "k_numbers": [ "K213919" ], "product_description": "Brand Name: Dexcom G7 Continuous Glucose Monitoring System\nProduct Name: Dexcom G7 CGM Android App\nModel/Catalog Number: SW12299\nSoftware Version: version 2.8.0 and earlier\nProduct Description: Dexcom G7 CGM Android App SW12299\nComponent: Dexcom G7 Continuous Glucose Monitoring System", "code_info": "Lot Code: UDI: SW12299 - 00386270001870", "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": "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 App. 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 Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment.", "root_cause_description": "Software design", "action": "On 07/24/2025, the firm sent an \"URGENT: MEDICAL DEVICE CORRECTION NOTIFICATION\" via in-app messaging informing users that a software bug was identified with users using the following app version:\n-Dexcom ONE+ iOS/Android App version 1.4 and all earlier versions,\n-Dexcom G7 iOS/G7 Watch iOS/Android App versions 2.8 and earlier\nThe software bug can cause an issue where, when a transmitter error occurs, the app terminates the sensor session and prompts the user to \"start a new sensor\" without providing a \"sensor failed\" alert.\n\nCustomer are instructed that an upgrade from app version version the affected software versions is mandatory and users will not be able to to use the affected app versions after August 20, 2025. To update their app now to continue to use the app:\n1. Tap Update App to go to the app store.\n2. Install the latest Dexcom ONE+ app version or Dexcom G7 app version\n3. Open the Dexcom ONE+ app or the G7 app\n\nIf assistance is needed, contact Technical Support\nU.S.: 1-844-478-1600\nGlobal: Find local Technical Support contact information at Dexcom.com", "product_quantity": "532821", "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 \n\nSW12300 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 \n\nSW14245 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\n\nSW14244 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", "openfda": { "k_number": [ "K183206", "K223435", "K261402", "K191450", "DEN170088", "K200876", "K243214", "K240902", "K221259", "K213919", "K231081", "K234133", "K222447", "K223931", "K253737", "K253710", "K201328", "K233537" ], "registration_number": [ "3033394445", "2954323", "3004111573", "3013820501", "3016904853", "3010220595", "3011120183", "2032098", "3019807891", "3004105270", "3002807314", "3006371704", "2024024", "3013435121", "3012302888", "3008717264", "3021611414", "3027503105", "2030598", "3037326582", "3038285067", "3003600763", "3009888344", "9710492", "3006537560", "2029015", "3007421145", "3002807090", "3011536730", "3009901017", "3012448339", "1450743", "3004753838" ], "fei_number": [ "3033394445", "3004111573", "3013820501", "3016904853", "3010220595", "3011120183", "3019807891", "3006003617", "3004105270", "3002807314", "3006371704", "2024024", "3013435121", "3012302888", "3008717264", "3021611414", "3027503105", "3002803444", "3003058448", "1000160458", "3037326582", "3038285067", "3003600763", "3009888344", "3004173703", "1000518731", "3006537560", "3011536730", "3009901017", "3012448339", "1450743", "3004753838", "3003500908" ], "device_name": "Integrated Continuous Glucose Monitoring System, Factory Calibrated", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1355", "device_class": "2" } } ] }