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U.S. Department of Health and Human Services

Class 2 Device Recall Dexcom G7 Continuous Glucose Monitoring System

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 Class 2 Device Recall Dexcom G7 Continuous Glucose Monitoring Systemsee related information
Date Initiated by FirmApril 14, 2026
Date PostedMay 11, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2164-2026
Recall Event ID 98639
510(K)NumberK240902 K243214 
Product Classification Integrated Continuous Glucose Monitoring system, factory calibrated - Product Code QBJ
ProductBrand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone app and the versions used are the same for each user. The watchOS app cannot be installed independently from the iOS phone app. Component: Dexcom G7 Continuous Glucose Monitoring System, Dexcom G7 15 Day Continuous Glucose Monitoring System
Code Information Lot Code: SW13355 versions 2.9.0 through 2.11.2 - UDI-DI: 00386270005168
FEI Number 3004753838
Recalling Firm/
Manufacturer		 Dexcom, Inc.
6340 Sequence Dr
San Diego CA 92121-4356
For Additional Information ContactTim Peterson
1-858-5294548
Manufacturer 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a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
FDA Determined
Cause 2		Software design
ActionOn 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. Required Customer Actions: Updating 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: 1. Tap Update App to go to the app store 2. Install the latest Dexcom ONE+ iOS app version or Dexcom G7 iOS app version that applies to customer app/product used . 3. Open the appropriate Dexcom ONE+ iOS app, or Dexcom G7 iOS app For questions or assistance - contact Technical Support by finding local Technical Support via Dexcom.com/global.
Quantity in Commerce58582
DistributionSW12300 & 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. SW14245 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = QBJ
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