The Office of Developmental Programs (ODP) is sharing this important announcement from the U. S. Food and Drug Administration (FDA)

FDA MedWatch – Dexcom Recalls Certain Glucose Monitor Receivers for Missing Blood Sugar Level Alerts

Continuous Glucose Monitor Receiver Recall: Dexcom, Inc. Removes Certain Dexcom G6, G7, ONE, and ONE+ Receivers Due to Speaker Malfunction That May Cause Missed Alerts for Dangerous Blood Sugar Levels

• Medical Device Recalls

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

• Product Names: Dexcom G6 Receiver, Dexcom G7 Receiver, Dexcom ONE Receiver, Dexcom ONE+ Receiver (note: The Dexcom ONE and ONE+ Receivers are only available outside the US)
• Unique Device Identifier (UDI)/Model: See full list of affected devices.
• Lot/Serial Numbers: See full list of affected devices.

What to Do

1. Check product list to see if your product is affected
2. Contact Dexcom for a replacement
3. Test your speaker regularly

On June 9, 2025, Dexcom, Inc. sent all affected customers an Urgent Medical Device Correction – UpdateExternal Link Disclaimer recommending the following actions:

• Visit dexcom.com/checkreceiverExternal Link Disclaimer to see if your receiver is affected.
  • If so, contact Dexcom Technical Support at 1-844-478-1600 to request a free replacement.
• Whether or not your receiver is affected, test your receiver’s speaker every time you charge it. You can also retest 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.

Reason for Recall

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.

Device Use 

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 healthcare facilities.

Contact Information

Customers in the U.S. with questions about this recall should contact Dexcom at 1-844-478-1600.

Additional FDA Resources:

• FDA’s Enforcement Report
• Medical Device Recall Database

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

• How do I recognize a UDI on a label?
• AccessGUDID database – Identify Your Medical Device
• Benefits of a UDI System

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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