# FDA recall Z-2446-2025

> **Dexcom, Inc.** · Class I · device recall initiated 2025-07-24.

## Product

Brand Name: Dexcom G7 Continuous Glucose Monitoring System  Product Name: Dexcom G7 CGM Android App  Model/Catalog Number: SW12299  Software Version: version 2.8.0 and earlier  Product Description: Dexcom G7 CGM Android App SW12299  Component: Dexcom G7 Continuous Glucose Monitoring System

## Reason for recall

The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App. The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment.

## Distribution

SW12299 G7 Android CGM App   Worldwide Distribution - US Nationwide and the countries of Andorra, United Arab Emirates, Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, Iceland, Italy, Jordan, Japan, South Korea, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Qatar, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa   SW12300 G7 iOS CGM App   Worldwide Distribution - US Nationwide and the countries of United Arab Emirates, Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Iceland, Italy, Jordan, Japan, South Korea, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Qatar, Saudi Arabia, Sweden, Slovenia, Slovakia

## Key facts

- **Recall number:** Z-2446-2025
- **Recalling firm:** Dexcom, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-24
- **Report date:** 2025-09-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2446-2025

## Citation

> AI Analytics. FDA recall Z-2446-2025. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-2446-2025. Source: US FDA. Licensed CC0.

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