Dexcom, Inc.: Brand Name: Dexcom One+ Continuous Glucose Monitoring System Product Name: Dexcom One+ Ios Cgm App Model/catalog Number: Sw14244 Software Version: ...
Dexcom ONE+ iOS App Recall Summary Dexcom is recalling versions 1.5.0 and 1.6.0 of the Dexcom ONE+ iOS app due to a software defect that can delay glucose readings and alerts when the app runs in the background. In severe cases, the app may incorrectly signal loss of connection, and users may see outdated glucose values or miss critical high or low blood sugar notifications. The recall affects users in the US, Canada, Europe, the Middle East, Asia, Australia, and New Zealand.
- 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
- 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/78d4bb69-48db-4b51-b34d-d15d8a567bf8