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
What to Do
- Check product list to see if your product is affected
- Contact Dexcom for a replacement
- Test your speaker regularly
On June 9, 2025, Dexcom, Inc. sent all affected customers an Urgent Medical Device Correction – Update recommending the following actions:
- Visit dexcom.com/checkreceiver 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 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.
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 health care facilities.
Contact Information
Customers in the U.S. with questions about this recall should contact Dexcom at 1-844-478-1600.
Full List of Affected Devices
| Product | Unique Device Identifier (UDI)/Model | Lot/Serial Numbers |
|---|---|---|
| G6 | STK-FM-001 (MT27408-1) | 00386270003232 |
| G6 | STK-FR-001 (MT27408-1) | 00386270003225 |
| G7 | STK-AT-011 (MT26403-0) | 00386270002198 |
| G7 | STK-AT-012 (MT26403-0) | 00386270002518 |
| G7 | STK-AT-013 (MT26403-0) | 00386270002525 |
| G7 | STK-GT-001 (MT26403-1) | 00386270004291 |
| G7 | STK-GT-008 (MT26403-5) | 00386270004260 |
| G7 | STK-GT-013 (MT26403-1) | 00386270002273 |
| G7 | STK-GT-019 (MT26403-4) | 04595986293080 |
| G7 | STK-GT-100 (MT26403-2) | 00386270002020 |
| G7 | STK-GT-109 (MT26403-2) | 00386270002129 |
| G7 | STK-GT-113 (MT26403-3) | 00386270003638 |
| ONE | STK-DO-006 (MT27409-1) | 00386270003188 |
| ONE | STK-DO-013 (MT27409-1) | 00386270002327 |
| ONE | STK-DO-103 (MT27409-2) | 00386270002969 |
| ONE | STK-DO-109 (MT27409-2) | 00386270002792 |
| ONE+ | STK-D7-013 (MT28285-1) | 00386270003812 |
| ONE+ | STK-D7-014 (MT28285-1) | 00386270003843 |
| ONE+ | STK-D7-103 (MT28285-2) | 00386270003836 |
Additional FDA Resources:
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 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.
