Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model
Summary
The FDA issued a Class I for Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom by Dexcom, Inc.. 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 est.
Details
Source
Device Recall
External ID
Z-0318-2026
Action Date
2025-11-05
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: Lot Code: UDI: SW11678 - 00386270000811
Quantity Affected: 333
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).
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-28
Company
San Diego, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 284 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Dexcom, Inc. has 33 FDA actions in our database, including 17 recalls and 16 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Dexcom, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Dexcom, Inc. have FDA actions?
Dexcom, Inc. has 33 FDA actions in our database, including 17 recalls and 16 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0318-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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