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FDA-Device2026-05-20Class IIPROCESSING DEFECT

Dexcom G7 watchOS app recalled for delayed glucose alerts and signal loss risk

Dexcom
OTHERNationwide distribution

Dexcom G7 watchOS app recalled for delayed glucose alerts

A software defect in the Dexcom G7 watchOS app (versions 2.9.0–2.11.2) can delay glucose value notifications and alerts when the app runs in the background. When you open the app, older glucose readings may flash on screen, and the app may incorrectly report a loss of signal. This delay could cause you to miss alerts for dangerously high or low blood sugar, or make treatment decisions based on outdated information.

  • Update your Dexcom G7 app to the latest version as soon as it becomes available
  • In the meantime, check your glucose readings more frequently on your phone rather than relying solely on watch notifications
  • If you use your Dexcom G7 watchOS app, monitor for outdated or delayed glucose readings
Hazard

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a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.

Sold states
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. 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.
Affected count
58582
Manufactured in
6340 Sequence Dr, San Diego, CA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2164-2026

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