Reported Nov 5, 2025 · Ongoing
Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App…
Dexcom, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dexcom, Inc. · 6340 Sequence Dr · San Diego, CA · 92121-4356
Is this the product you have?
- Brand NameDexcom G6 Continuous
- Glucose Monitoring System Product NameDexcom G6 and G6 Pro
- Android US CGM App Model/Catalog NumberSW11678
- Software Versionversion 1.15.0
- Product DescriptionDexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0
- ComponentDexcom G6 Continuous Glucose Monitoring System
- Lot codes and dates
- Lot CodeUDI: SW11678 - 00386270000811
- Amount recalled
- 333
Why it was recalled
Stop using this product now
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).
Using this product could cause serious injury, illness or death — stop using it now.
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