Dexcom Continuous Glucose Monitor Recall Issued Following Dozens of Injuries: FDA

Manufacturer is recalling devices after more than 50 injury reports related to speaker systems failing to alert users of dangerous blood sugar levels.

Federal health officials are warning that certain Dexcom glucose monitors may fail to sound alerts for dangerously high or low blood sugar levels, due to a potential defect.

The Dexcom continuous glucose monitor receiver recall was announced by the U.S. Food and Drug Administration (FDA) on July 17, after at least 56 injuries were linked to the issue.

Dexcom receivers are used at home or in healthcare settings, as part of a continuous glucose monitoring system, designed to track real-time glucose levels and alert users when intervention is needed.

However, officials warn that a speaker defect in some units may prevent the alarm from sounding, potentially resulting in serious health consequences, such as seizures, vomiting, loss of consciousness or death.

While no deaths have been reported, the FDA has categorized this action as a Class I recall, the most severe type, indicating that continued use of the affected devices could result in life-threatening complications. 

The recall impacts the following Dexcom products with corresponding Unique Device Identifier (UDI) numbers:

• G6 receivers, UDI: STK-FM-001, STK-FR-001
• G7 receivers, UDI: STK-AT-011, STK-AT-012, ATK-AT-013, STK-GT-001, STK-GT-008, STK-GT-013, STK-GT-019, STK-GT-100, STK-GT-109, STK-GT-113
• ONE receivers, UDI: STK-DO-006, STK-DO-013, STK-DO-103, STK-DO-109
• ONE+ receivers, UDI: STK-D7-013, STK-D7-014, STK-D7-103

All impacted customers were sent an Urgent Medical Device Correction (PDF) on June 9, advising them to check their product inventory to determine if any devices are affected and, if so, to contact Dexcom for a free replacement.

Regardless of whether a receiver is affected, customers are advised to test the receiver’s speaker every time it is charged. Dexcom warns that even if the speaker beeps, it could still fail in the future without warning. The speaker can be re-tested at any time. If the speaker does not beep during testing, contact Dexcom immediately.

Customers with questions or who need a free replacement can contact Dexcom at 1-844-478-1600.

Health care professionals and other consumers may also report issues with the affected devices to the FDA’s safety information and adverse event reporting program, Medwatch.

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