# FDA recall Z-0318-2026

> **Dexcom, Inc.** · Class I · device recall initiated 2025-08-28.

## Product

Brand Name: Dexcom G6 Continuous Glucose Monitoring System  Product Name: Dexcom G6 and G6 Pro Android US CGM App  Model/Catalog Number: SW11678  Software Version: version 1.15.0  Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0  Component: Dexcom G6 Continuous Glucose Monitoring System

## Reason for recall

A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. This could result in the missed detection of a hyperglycemic or hypoglycemic event, protentional resulting in severe hyperglycemia, diabetic ketoacidosis (DKA), or hyperosmolar hyperglycemic state (HHS).

## Distribution

This product was distributed throughout the US. G6 Android US v1.15.0 SW11678 G6 and G6 Pro Android app release has been halted <1% rollout after this issue was identified. Please see the attached consignee data for additional details.

## Key facts

- **Recall number:** Z-0318-2026
- **Recalling firm:** Dexcom, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-28
- **Report date:** 2025-11-05

- **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-0318-2026

## Citation

> AI Analytics. FDA recall Z-0318-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0318-2026. Source: US FDA. Licensed CC0.

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