{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "219288", "product_res_number": "Z-2163-2026", "event_date_initiated": "2026-04-14", "event_date_posted": "2026-05-11", "recall_status": "Open, Classified", "res_event_number": "98639", "product_code": "QBJ", "k_numbers": [ "K240902", "K243214" ], "product_description": "Brand Name: Dexcom G7 Continuous Glucose Monitoring System\nProduct Name: Dexcom G7 CGM iOS App\nModel/Catalog Number: SW12300\nSoftware Version: Versions 2.9.0 through 2.11.2\nProduct Description: Dexcom G7 CGM iOS App\nComponent: Dexcom G7 Continuous Glucose Monitoring System, Dexcom G7 15 Day Continuous Glucose Monitoring System", "code_info": "Lot Code: SW12300 versions 2.9.0 through 2.11.2 - UDI-DI: 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": "Tim Peterson\n1-858-5294548", "reason_for_recall": "A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then \"replay\" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.", "root_cause_description": "Software design", "action": "On 04/14/2026, the firm sent via the iOS App an \"URGENT: MEDICAL DEVICE CORRECTION NOTIFICATION\" communication informing customers that a software error was identified within app versions 1.5 to 1.6 and G7 iOS / G7 Watch iOS app v2.9.0 through v2.11.2 that can cause the app display to flicker sequentially through previous estimated glucose values (EGVs) and trend arrows before displaying the current EGV and trend arrow with the potential to delay glucose alerts.\n\nRequired Customer Actions:\nUpdating from app versions 1.5-1.6 to the most current version is mandatory and you will not be able to use app versions 1.5 to 1.6 after April 30, 2026. Update your app now to continue using the app:\n1. Tap Update App to go to the app store\n2. Install the latest Dexcom ONE+ iOS app version or Dexcom G7 iOS app version that applies to customer app/product used .\n3. Open the appropriate Dexcom ONE+ iOS app, or Dexcom G7 iOS app\n\nFor questions or assistance - contact Technical Support by finding local Technical Support via Dexcom.com/global.", "product_quantity": "58582", "distribution_pattern": "SW12300 & SW13355 Dexcom G7 iOS and watchOS app versions 2.9.0 through 2.11.2: Worldwide - US Nationwide including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Austria, Australia, Belgium, Bahrain, Canada, Czech Republic, Germany, Denmark, Estonia, Finland, France, Hong Kong, Ireland, Israel, Iceland, Italy, Jordan, Japan, Kuwait, Luxembourg, Malta, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom.\n\nSW14245 Dexcom ONE iOS App versions 1.5.0 and 1.6.0 - Only International distribution to the countries of Andorra, Australia, Belgium, Bulgaria, Czech Republic, Estonia, France, Greece, Croatia, Ireland, Italy, Lithuania, Latvia, Malaysia, Monaco, Netherlands, New Zealand, Poland, Qatar, Romania, Saudi Arabia, Spain, Sweden, United Kingdom.", "openfda": { "k_number": [ "K213919", "K231081", "K201328", "K240902", "K253737", "K223931", "K222447", "K253710", "K243214", "DEN170088", "K221259", "K223435", "K233537", "K200876", "K261402", "K191450", "K183206", "K234133" ], "registration_number": [ "3011120183", "3012448339", "2032098", "3033394445", "3012302888", "3009888344", "2954323", "2024024", "3008717264", "3004753838", "3004105270", "3016904853", "1450743", "3006371704", "3009901017", "3006537560", "3027503105", "3004111573", "3002807314", "3013820501", "3013435121", "2030598", "9710492", "3011536730", "2029015", "3010220595", "3019807891", "3003600763", "3037326582", "3038285067", "3007421145", "3002807090", "3021611414" ], "fei_number": [ "3011120183", "3012448339", "3033394445", "3012302888", "3006003617", "3009888344", "2024024", "3008717264", "3004753838", "3004105270", "3016904853", "1450743", "3006371704", "3009901017", "3006537560", "1000518731", "3027503105", "3004111573", "3003058448", "3004173703", "3002807314", "3013820501", "3013435121", "1000160458", "3011536730", "3010220595", "3019807891", "3003600763", "3037326582", "3038285067", "3002803444", "3003500908", "3021611414" ], "device_name": "Integrated Continuous Glucose Monitoring System, Factory Calibrated", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1355", "device_class": "2" } } ] }