Z-0318-2026Class I

Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM...

Name: Z-0318-2026 Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM...
Creator: Dexcom, Inc.
Published: 2025-08-28
License: https://open.fda.gov/license/

Dexcom, Inc. / initiated 2025-08-28 / Open, Classified / root cause: software

FDA source

Dexcom, Inc. began a recall of Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software... on 2025-08-28. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0318-2026
Classification: Class I
Status: Open, Classified
Initiated: 2025-08-28
Posted: 2025-10-30
Recalling firm: 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
Product code: QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
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).
Root cause tag: software
FDA root cause: Software Design Change
Action: On 09/18/2025, the firm sent via in-app and email an "URGENT: MEDICAL DEVICE CORRECTION NOTIFICATION" communication informing customer that a bug has been identified within the G6 Android app version 1.15.0 that can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, or alerts. Customers are instructed to: Upgrading from app version 1.15.0 is mandatory and they will not be able to use app version 1.15.0 after October 6th, 2025. Update your app now to continue using the app: 1. Open the App Store and search for the Dexcom G6 app. 2. Install the latest Dexcom G6 app version. 3. Open the Dexcom G6 app. For questions or further assistance - contact Technical Support at 1-844-478-1600. Technical Support is available 24 hours a day/7 days a week
Quantity in commerce: 333
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.
Product codes and lots: Lot Code: UDI: SW11678 - 00386270000811

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0318-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0318-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-30

Product code QBJ

K223931Class IIDexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. / cleared 2023-01-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)