Dexcom, Inc. recalls Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6
- Recalling company
- Dexcom, Inc.
- 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
- 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).
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Aug 28, 2025
- Reported
- Nov 5, 2025
- 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.
- Status
- Ongoing
- Quantity
- 333
- Lot / codes
- Lot Code: UDI: SW11678 - 00386270000811
- Company location
- San Diego, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0318-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0318-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.