Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0318-2026 — 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 Glu

U.S. FDA — Device Enforcement · United States · 2025-08-28 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0318-2026
Date of alert
2025-08-28
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Dexcom, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00386270000811
Reported risk: 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).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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