The Recall Desk
HighFDA (Devices)·Z-1204-2025·Announced 2025-02-26

Dexcom G6 Glucose Monitoring System Receiver May Fail to Deliver Critical Alarms

The Dexcom G6 receiver may rarely fail to deliver or delay glucose alarms due to a software error, potentially missing dangerous blood sugar events. No illnesses have been reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving delayed or missed critical glucose monitoring alarms. The source explicitly states no illnesses or injuries have been reported. The hazard qualifies as a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for High severity.

Plain-English summary

The Dexcom G6 Continuous Glucose Monitoring System receiver is subject to a recall due to rare operating system errors that can prevent proper delivery of critical glucose alarms and alerts.

Under very rare circumstances, a .NET operating system error may prevent the receiver from delivering high or low glucose alarms as designed. When this occurs, the initial alarm fails to deliver until a second alarm is triggered. When the second alarm occurs, the first alarm is delivered but the second is not. This creates a cascading delay, with each alarm delayed behind the next one until the receiver is reset. This condition could result in delayed detection of dangerous blood sugar events (hyperglycemic or hypoglycemic episodes).

Additionally, a single blood glucose reading may be delayed by up to 5 minutes following the initial operating system error, though the manufacturer states this 5-minute delay is not expected to cause user harm.

Affected users should contact Dexcom, Inc. for further guidance. The recall affects units with all serial numbers and includes distribution in the United States and multiple international markets.

The recalled product

Product
Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001
Manufacturer
Dexcom, Inc.
Category
Medical Device — Continuous Glucose Monitoring System
Hazard

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)

  • All Serial Numbers/UDI: 00386270001900

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Dexcom, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Dexcom, Inc.

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