Dexcom Recalls CGM Receiver Devices Due to Alert Malfunction

Dexcom has recalled its G6, G7, ONE, and ONE+ continuous glucose monitor (CGM)receivers due to a speaker malfunction that could cause missed low or high blood sugar alerts.

The recall, for which Dexcom notified customers in June, was announced by the FDA on July 17, 2025. A problem with the speaker may cause it to fail to make an alert sound for low or high blood sugar. Potential adverse effects include seizures, vomiting, loss of consciousness, or death. A total of 56 injuries have been reported but no deaths.

The recall only affects the stand-alone receiver devices not the smartphone apps or the receivers built into insulin pump devices as part of automated insulin delivery systems. The Dexcom ONE and ONE+ are only available outside the US, the FDA noted.

“In rare circumstances, certain Dexcom CGM receivers may experience issues with audio alerts and alarms due to the speaker not functioning as intended. This recall does not impact users who use Dexcom mobile apps as the display device for their glucose values, alerts, and alarms, which constitutes a majority of our users globally. For the affected receivers which have been distributed, about 700,000, the reported incidence rate is 0.015%,” a Dexcom spokesperson told Medscape Medical News.

The FDA advises that customers do the following:

• Check product list to see if your product is affected using www.Dexcom.com/check-receiver.
• Contact Dexcom for a replacement.
• Test your speaker every time you charge the device, whether or not your receiver is affected. 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.
• Make sure everyone who relies on the receiver for alerts — ie, anyone with whom the readings are shared — knows about this possible problem.

“We are actively working with local regulatory agencies. If the user has an affected device, Dexcom will provide a no-cost replacement,” the Dexcom spokesperson said.

Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR’s Shots blog, and Diatribe. She is on X @MiriamETucker and BlueSky @miriametucker.bsky.social.