The U.S. Food and Drug Administration (FDA) has issued a Class I recall—its most serious warning—affecting over 2.2 million Dexcom glucose monitoring devices. These medical devices, widely used by people with diabetes, may fail to sound an alarm when blood sugar levels become dangerously high or low.
The recall involves four Dexcom products: the G6 Glucose Receiver, G7 Glucose Receiver, One+ Continuous Glucose Monitoring System, and One Continuous Glucose Monitoring System. A defect in the speaker system, caused by either faulty foam or assembly errors, can cause the speaker to lose contact with the internal circuit board. This prevents the devices from emitting audible alerts.
Without sound alerts, users may not realize when they are experiencing dangerously abnormal blood sugar levels. This can result in missed treatments, leading to serious health consequences such as seizures, fainting, vomiting, or even death from untreated hypoglycemia or hyperglycemia.
Dexcom first acknowledged the issue in May, stating that a limited number of G6 and G7 receivers were affected. The company clarified that the devices would still deliver vibration and visual alerts, even if the sound failed. At that time, 112 global complaints had been confirmed to be linked to the faulty speaker. At least 56 serious health incidents were reported, including seizures and loss of consciousness.
The majority of affected units are G7 receivers, with more than 1.9 million requiring recall. Other impacted products include more than 182,000 Dexcom G6 receivers, 76,000 Dexcom One units, and 59,000 Dexcom One+ monitors.
SKU codes for the recalled devices are as follows:
Dexcom G6 Glucose Receiver:
- STK-FE-001 (MT27408-1)
- STK-FM-001 (MT27408-1)
- STK-FR-001 (MT27408-1)
Dexcom G7 Glucose Receiver:
- STK-AT-011, STK-AT-012, STK-AT-013
- STK-GT-008, STK-GT-013, STK-GT-019
- STK-GT-100, STK-GT-102, STK-GT-109
- STK-GT-113, STK-GT-120
(All with respective MT26403 serial codes)
Dexcom One+ Monitoring System:
- STK-D7-013, STK-D7-014
- STK-D7-102, STK-D7-103, STK-D7-109
Dexcom One Monitoring System:
- STK-DO-006, STK-DO-013
- STK-DO-103, STK-DO-109
Dexcom’s wearable systems use small sensors worn on the arm or abdomen, which continuously measure blood sugar levels. These sensors connect to receivers or smartphones to alert users when glucose levels are outside the safe range. G6 and G7 systems use handheld receivers, while the One and One+ models connect to smartphone apps without a separate receiver.
These devices are sold in 42 countries, including the U.S., UK, Canada, France, Australia, Japan, Saudi Arabia, and South Africa. They have become essential tools for many people with diabetes, offering an alternative to traditional finger prick testing.
For users, the key risk is the failure of the device to provide an audible alert. While visual and vibration alerts still function, the absence of sound could be especially dangerous for individuals who are asleep or otherwise unable to notice the other warnings.
The FDA’s Class I designation indicates that continued use of these products could result in serious injury or death.
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