The Recall Desk
HighFDA (Devices)·Z-1202-2025·Announced 2025-02-26

Dexcom G6 Glucose Monitor May Fail to Deliver Alarms Properly

Dexcom G6 continuous glucose monitors may fail to deliver high or low blood sugar alarms due to a software error, potentially delaying detection of dangerous glucose levels. Alarms will be delayed and skip in sequence until the device is reset.

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 FDA Class II recall involves a documented software defect affecting a critical safety function (glucose level alerts) with no reported injuries or illnesses. The hazard represents a clear risk of delayed or missed detection of life-threatening hypoglycemic and hyperglycemic events, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Dexcom, Inc. is recalling Dexcom G6 continuous glucose monitoring systems that use touchscreen receivers (REFs: STK-OM-001, STR-OM-001, STR-OR-001) with serial numbers 00386270000583. The Dexcom G6 is a wearable glucose monitor designed to provide real-time alerts for high and low blood sugar levels.

Under very rare conditions, a software error in the receiver's .NET operating system can prevent alarms and alerts from being delivered as designed. When this error occurs, the initial alarm is not delivered until a subsequent alarm is triggered. At that point, the initial alarm is delivered, but the second alarm is not. This pattern continues with alarms being delayed and one alarm behind the actual event until the receiver is reset. Additionally, a single glucose reading (EGV) may be delayed by up to 5 minutes after the initial error. The manufacturer states that the 5-minute reading delay is not expected to cause user harm.

The primary hazard is that missed or delayed alarms could prevent users from detecting hyperglycemic (dangerously high) or hypoglycemic (dangerously low) blood sugar events when they occur. This is particularly concerning for people with diabetes who rely on timely alerts to make treatment decisions. Affected devices were distributed worldwide including throughout the United States (OH, TX, PA, MN, SC, NH, FL, CA, NJ, PR, GA) and internationally to multiple countries.

Dexcom has released an updated software version to address the alarm delivery issue. Users of affected Dexcom G6 systems should contact Dexcom for instructions on updating their device firmware. If you experience delayed or missed alarms on your Dexcom G6, reset the receiver immediately and contact Dexcom customer support.

The recalled product

Product
Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001
Manufacturer
Dexcom, Inc.
Category
Medical Device — Continuous Glucose Monitoring
Hazard
  • missed-alerts
  • delayed-readings

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: 00386270000583

Distribution

Distributed nationwide across the United States.

Related recalls

Same category