FDA Assigns Blood Sugar Tracker Its Highest Recall Alert

An FDA advisory states that some Continuous Glucose Monitor Receivers may skip dangerous blood sugar level alerts in diabetics.

Juliette Fairley

Published: 7/18/2025, 5:48:18 PM EDT

FDA Assigns Blood Sugar Tracker Its Highest Recall Alert — Photo of recalled devices. (Courtesy of Dexcom consumer alert)

The U.S. Food and Drug Administration (FDA) assigned its highest risk designation to a medical device that is designed to issue alerts when blood sugar in humans is too high or too low.

Consumers use the device to measure the severity of hypoglycemia, which the Mayo Clinic states is a condition in which glucose or blood sugar level is lower than the standard range.

“There have been at least 56 reported injuries,” an FDA alert stated. “There have been no reports of death.”

Concerns that a Continuous Glucose Monitor Receiver may skip dangerous blood sugar level alerts in diabetics led Dexcom to voluntarily recall the device last month, according to a July 17 FDA advisory.

“Whether or not your receiver is affected, test your receiver’s speaker every time you charge it,” the FDA said. “You can also re-test the sound at any time using the device menu. If the speaker does not beep when you test it, contact Dexcom right away. If the speaker beeps, be mindful that it may still fail without warning in the future.”

The FDA has designated the recall a Class 1 event.

A Class 1 event is the FDA’s highest risk alert and is described on the FDA website as having a reasonable probability that the use of or exposure will cause serious adverse health consequences or death.

A Class 2 recall is for products that might cause temporary or reversible health issues, but where the risk of serious harm is lower and Class 3 recalls involve products that violate regulations but are unlikely to cause health problems, such as minor labeling errors, according to Northeastern University professor, food safety expert, and Alliance for Recall Ready Communities adviser Darin Detwiler.

The recall applies to Dexcom G6, G7, ONE, and ONE+ receivers, which are part of continuous glucose monitoring systems that help people with diabetes track glucose levels in real time.

The device is used by individual consumers at home or in health care facilities.

"In rare circumstances, certain Dexcom CGM receivers may experience issues with audio alerts and alarms due to the speaker not functioning as intended,” company leaders told NTD in an email. “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 (~700,000), the reported incidence rate is 0.015%.”

Use of the recalled product may cause serious adverse health consequences, including seizures, vomiting, loss of consciousness, and death, according to the FDA.

If a user has an affected device, Dexcom says it will provide a no-cost replacement. Customers can check if their receiver is impacted at https://www.dexcom.com/checkreceiver.

"If a user experiences a lack of receiver audio due to this issue, it may result in delayed and/or missed detection of severe hypoglycemia or hyperglycemia," a Dexcom consumer alert stated. "Although a speaker test could identify a defective receiver, the malfunction can occur at any time without warning, even if the receiver has recently passed the speaker test."