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FDA-Device2026-05-20Class IIPROCESSING DEFECT

Dexcom G7 iOS app recalled for delayed glucose alerts and notifications

Dexcom
OTHERNationwide distribution

Dexcom G7 iOS app recalled for delayed glucose alerts

A software defect in the Dexcom G7 continuous glucose monitoring app (versions 2.9.0–2.11.2 for iOS) can delay glucose value updates and alerts when the app runs in the background. When you open the app, notifications may replay in sequence or show outdated readings. In some cases, the app may incorrectly detect signal loss, creating a risk that users could miss high or low blood sugar alerts or make treatment decisions based on outdated information.

  • Update your Dexcom G7 iOS app to version 2.11.3 or later from the Apple App Store
  • If you cannot update immediately, keep the app open and active on your device when possible
  • Contact Dexcom support if you experience missed alerts 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a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.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 iOS App Model/Catalog Number: SW12300 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM iOS 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-2163-2026

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