Dexcom, Inc.: Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 Cgm Watchos App Model/catalog Number: Sw13355 Software Version: ...
Dexcom G7 Recall Summary Dexcom is recalling certain versions of its G7 continuous glucose monitoring app for iPhones and Apple Watches (software versions 2.9.0 through 2.11.2) worldwide due to a software glitch that can delay glucose readings and alerts. When the app runs in the background, glucose value notifications may queue up and display old information when reopened, or the app may incorrectly detect signal loss, which risks users missing low or high blood sugar events or making treatment decisions based on outdated data. The recall also includes certain versions of the Dexcom ONE iOS app distributed internationally.
- Recalling firm
- Dexcom, Inc.
- Product
- Brand 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
- Reason
- 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...
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-14
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- 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,...
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/9fa5b394-0b06-486d-97cb-23b2dda295fc