Updated: Dexcom recalls more than 700K CGM receivers over safety issues—dozens of adverse events reported

Michael Walter | June 18, 2025 | Cardiovascular Business | Heart Health

Dexcom has issued four separate recalls for its continuous glucose monitoring (CGM) systems due to audio issues that could result in missed alerts. The U.S. Food and Drug Administration categorized these as Class I recalls, which means using these devices could result in death or other serious health consequences.

Editor's Note: The agency originally reported that this issue involves more than 2.2 million devices in total. However, it has updated those numbers to show that the issue involves more than 703,000 devices. This includes more than 36,000 Dexcom G6 CGMs, more than 602,000 Dexcom G7 CGMs, more than 38,000 Dexcom One CGMs and more than 26,000 Dexcom One+ CGMs.

“Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values,” according to the recall alerts. “A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.”

Customers have been urged to look online to see if their equipment has been affected by this issue. Dexcom is replacing all CGMs included in these recalls at no charge.

The Dexcom G7 Continuous Glucose Monitoring System

The Dexcom G7 CGM.

Even if a customer’s CGM is not included in this recall, Dexcom recommends it be regularly tested to ensure the alarms are working as intended.

According to an Urgent Medical Device Correction focused on the G6 and G7 CGMs, a total of 56 adverse events have been reported so far due to these issues. This includes seizures, vomiting, loss of consciousness and other serious reactions. However, the company noted, all patients fully recovered.

Dexcom shares a statement

“In rare circumstances, certain Dexcom CGM receivers may experience issues with audio alerts and alarms due to the speaker not functioning as intended,” a Dexcom spokesperson told Cardiovascular Business. “This recall does not impact users who use Dexcom mobile apps as the display device for their glucose values, alerts and alarms, which constitutes a majority of our users globally. For the affected receivers which have been distributed, the reported incidence rate is 0.015%.”

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Michael Walter, Managing Editor

Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.

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