Dexcom, Inc.: Integrated Continuous Glucose Monitoring System, Factory Calibrated
Dexcom ONE+ Recall Summary Dexcom is recalling certain versions of their ONE+ and G7 continuous glucose monitoring apps due to a software defect that can delay or prevent glucose readings and alerts from appearing on the screen. This defect may cause users to miss notifications of dangerously high or low blood sugar levels or make treatment decisions based on outdated information. The recall affects users in the United States and multiple international countries who have the affected software versions installed on their iOS devices.
- Recalling firm
- Dexcom, Inc.
- Product
- Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ 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
- FDA-DEVICES
- Recall date
- 2026-04-14
- Status
- Open, Classified
- 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 FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/4a1ccdd3-d427-4b67-b925-6cf22220fe22