Recall for medical device used by millions over critical malfunction

An urgent recall has gone out for a popular medical device used by millions of Americans with diabetes.

The US Food and Drug Administration (FDA) has revealed that over two million blood glucose monitors from Dexcom could fail to give the audible warning that the wearer is dealing with high or low blood sugar levels.

This could lead to users missing critical warnings, increasing the risk of serious health problems like seizures, vomiting, fainting, or even death from untreated hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar).

The recall effects the Dexcom G6 Glucose Receiver, Dexcom G7 Glucose Receiver, Dexcom One+ Continuous Glucose Monitoring System, and the Dexcom One Continuous Glucose Monitoring System.

In total, 2,230,770 Dexcom devices are a part of the recall. The FDA has just designated the recall as a ‘Class I’ alert, their most severe grade, which means the problem could cause serious harm or death.

The problem in all four devices revolves around defective foam or an assembly error that can cause the speaker in the devices to lose contact with the internal circuit board.

This can cause the wearable monitor to stop sounding an alarm when the user’s blood sugar enters dangerous zones.

Over 38 million Americans have diabetes. Nearly 100 million American adults have prediabetes, according to data and estimates from the CDC.

Dexcom issued a statement in May which only cited the issues with a small number of the G6 and G7 receivers.

At the time, they noted that the problem only impacted the sound their receivers made and would not prevent the device from sending out a vibration or visual prompts to wearers.

‘As of May 2025, 112 complaints have been received globally with confirmed association to this speaker malfunction,’ Dexcom reported.

Globally, there were 56 reports of severe health problems tied to the speaker failure, including wearers having seizures, losing consciousness, and vomiting. 

For the Dexcom G6 Glucose Receiver, the FDA said the massive recall effects monitors with the SKU codes STK-FE-001 (MT27408-1), STK-FM-001 (MT27408-1), and STK-FR-001 (MT27408-1).

The recall also affects Dexcom G7 Glucose Receivers with the SKUs STK-AT-011 (MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0), STK-GT-008 (MT26403-5), STK-GT-013 (MT26403-1), STK-GT-019 (MT26403-4), STK-GT-100 (MT26403-2), STK-GT-102 (MT26403-2), STK-GT-109 (MT26403-2), STK-GT-113 (MT26403-3), and STK-GT-120 (MT26403-2).

The Dexcom G7 was impacted the most by this malfunction. Over 1.9 million of these blood glucose monitors will need to be pulled from stores or returned by users over the issue.

The new recall also affects Dexcom One+ Continuous Glucose Monitoring Systems with the SKUs STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-D7-102 (MT28285-2), STK-D7-103 (MT28285-2), and STK-D7-109 (MT28285-2).

Dexcom One Continuous Glucose Monitoring Systems with the SKUs STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), STK-DO-103 (MT27409-2), and STK-DO-109 (MT27409-2) have been recalled as well. 

More than 182,000 Dexcom G6 receivers, 76,000 Dexcom Ones, and 59,000 Dexcom One+ monitors are part of the current recall.

All of these devices work in a similar way, using a small sensor worn on the body (usually the arm or belly) and a transmitter that attaches to the sensor.

These wearables measure glucose levels continuously, alerting anyone who wears them when their body either has too much or too little sugar in their blood.

The receivers for the G6 and G7 are not worn on the body. They’re handheld devices users carry, like a small phone.

The Dexcom ONE and ONE+ don’t use a separate receiver. Instead, they rely on a smartphone app to show glucose data.

Dexcom devices are sold throughout the world in 42 countries, including the US, UK, Australia, Canada, France, Japan, Saudi Arabia, and South Africa.

Wearable sensors and transmitters like the Dexcom have made monitoring blood sugar levels easier for diabetics in recent years and have reduced the need for finger prick tests.