FDA Medical Device Recalls (openFDA)
Dexcom, Inc.: 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
- Recall number
- Z-0318-2026
- 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
- Status
- Open, Classified
- Initiated
- 2025-08-28
- Posted
- 2025-10-30
- Terminated
- not on file
- 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).
- 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
- 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.
- Lot, serial or model codes
- Lot Code: UDI: SW11678 - 00386270000811
- 510(k) numbers
- ["K223931"]
- PMA numbers
- not on file
- Product code
- QBJ
- Firm FEI
- 3004753838
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28