Dexcom, Inc. Recalls Certain Continuous Glucose Monitor Receivers

SAN DIEGO—Dexcom, Inc. is recalling certain Dexcom G6, G7, ONE and ONE+ glucose monitoring receivers because a problem with the speaker may cause it to fail to make an alert sound when blood sugar is dangerously low or high.

The use of affected product may cause serious adverse health consequences, including seizures, vomiting, loss of consciousness and death.

There have been at least 56 reported injuries. There have been no reports of death.

The Dexcom G6, G7, ONE and ONE+ receivers are part of continuous glucose monitoring systems that help people with diabetes track glucose levels in real time. The receiver issues alerts when blood sugar is too high or too low. These devices may be used at home or in health care facilities.

Patients can determine if their receiver is on the recall list by referencing the unique device identifier (UDI). 

What to Do

• Check product list to see if your product is affected
• If it is affected, contact Dexcom for a replacement by calling Dexcom Technical Support at 1-844-478-1600 to request a free replacement
• Test your speaker regularly: Whether or not your receiver is affected, test your receiver’s speaker every time you charge it. 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.
• Make sure everyone who relies on the receiver for alerts knows about this possible problem

For a full list of the recall products, visit fda.gov.