The Recall Desk
CriticalFDA (Devices)·Z-0318-2026·Announced 2025-11-05

Glucose monitoring app recalled because it can terminate and miss alerts

Dexcom is recalling version 1.15.0 of the G6 and G6 Pro Android CGM app because a software defect can terminate the app, stopping glucose values, alarms and alerts. The FDA classified it Class I.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the top severity regardless of other factors.

Plain-English summary

The Dexcom G6 and G6 Pro Android US CGM App, model SW11678, software version 1.15.0, a component of the Dexcom G6 Continuous Glucose Monitoring System, is being recalled.

A software defect in version 1.15.0 can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. Dexcom states this could result in the missed detection of a hyperglycemic or hypoglycemic event, potentially resulting in severe hyperglycemia, diabetic ketoacidosis (DKA), or hyperosmolar hyperglycemic state (HHS).

The recall covers 333 units carrying UDI 00386270000811 and was distributed throughout the United States. The FDA has classified the recall as Class I, its most serious category, used where there is a reasonable probability of serious injury or death.

People using the G6 Android app should check their app version and follow Dexcom's instructions.

The recalled product

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: Dexc
Manufacturer
Dexcom, Inc.
Category
Medical Device — Continuous glucose monitor
Hazard
  • software-defect
  • missed-alarms
  • class-i
  • diabetes
  • app-crash

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Code: UDI: SW11678 - 00386270000811

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category