The Recall Desk
HighFDA (Devices)·Z-1203-2025·Announced 2025-02-26

Dexcom G6 glucose receiver may fail to deliver high or low alarms

Under rare conditions, the Dexcom G6 receiver may fail to send high or low glucose alarms due to a software error, potentially delaying detection of dangerous blood sugar levels.

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 a Class II medical device recall with no reported illnesses or injuries. However, it qualifies as a risk-of-harm product where the malfunction (missed glucose alarms) could result in missed detection of hyperglycemic or hypoglycemic events. The hazard is theoretical, occurring under very rare conditions, with no reported patient harm.

Plain-English summary

The Dexcom G6 continuous glucose monitoring system receiver is being recalled because under rare conditions, the receiver may fail to deliver high or low glucose alarms as designed. The issue occurs when a .NET operating system error happens during an alarm trigger. The initial alarm is not delivered immediately; instead it is delayed until the next glucose alert occurs. At that point, the initial alarm is delivered, but the second alarm is not. This pattern continues with alarms remaining one event behind until the receiver is reset.

This malfunction could result in missed or delayed detection of hyperglycemic (high blood sugar) or hypoglycemic (low blood sugar) events. The recall also notes that a single glucose reading may be delayed by up to 5 minutes after the initial operating system error. According to the FDA, a 5-minute delay of a single reading is not expected to cause user harm.

Dexcom, Inc. has issued this Class II recall for all units with UDI 00386270000590, distributed worldwide including Ohio, Texas, Pennsylvania, Minnesota, South Carolina, New Hampshire, Florida, California, New Jersey, Puerto Rico, and Georgia. Users experiencing delayed or missing alarms should contact Dexcom or their healthcare provider.

The recalled product

Product
Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001
Manufacturer
Dexcom, Inc.
Category
Medical Device — Continuous Glucose Monitor
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: 00386270000590

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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Same hazard · missed alert

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