Dexcom, Inc. recalls Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and…
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).
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- 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 SystemUDI SW116782 affected lotsSW1167800386270000811
What the firm is doing
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
DistributionShow detailsHide
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.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0318-2026
- FDA 510(k) clearance · K223931The device's official FDA premarket clearance record
- FDA device classification · QBJOfficial FDA classification for this device type
- CFR regulation · 21 CFR 862.1355The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Dexcom, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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