Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number:
FDA device recall Z-2164-2026 · posted 2026-05-11 · Open, Classified
Recall details
- Recalling firm
- Dexcom, Inc.
- Reason for recall
- 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a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
- Action taken
- On 04/14/2026, the firm sent via the iOS App an "URGENT: MEDICAL DEVICE CORRECTION NOTIFICATION" communication informing customers that a software error was identified within app versions 1.5 to 1.6 and G7 iOS / G7 Watch iOS app v2.9.0 through v2.11.2 that can cause the app display to flicker sequentially through previous estimated glucose values (EGVs) and trend arrows before displaying the current EGV and trend arrow with the potential to delay glucose alerts. Required Customer Actions: Updating from app versions 1.5-1.6 to the most current version is mandatory and you will not be able to use app versions 1.5 to 1.6 after April 30, 2026. Update your app now to continue using the app: 1. Tap Update App to go to the app store 2. Install the latest Dexcom ONE+ iOS app version or Dexcom G7 iOS app version that applies to customer app/product used . 3. Open the appropriate Dexcom ONE+ iOS app, or Dexcom G7 iOS app For questions or assistance - contact Technical Support by finding local Technical Support via Dexcom.com/global.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- QBJ
- Quantity affected
- 58582
- 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,
- Date initiated
- 2026-04-14
- Date posted
- 2026-05-11
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Dexcom G7 15 Day Continuous Glucose Monitoring System (K243214) | Dexcom, Inc. | 2025-04-09 |
| Dexcom G7 Continuous Glucose Monitoring System (K240902) | Dexcom, Inc. | 2024-04-23 |