Dexcom recalls ONE+ glucose monitoring app versions 1.4.0 and earlier for missing sensor failure alerts, risking missed glucose events. Users should update to latest software.
The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App. The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment.
Dexcom is recalling its ONE+ Continuous Glucose Monitoring System app versions 1.4.0 and earlier because it doesn't alert users when the sensor fails. This could cause missed detection of high or low blood sugar events, leading to delayed treatment.
The app fails to show a 'Sensor Failed' alert when the transmitter detects hardware or firmware issues. Instead, it stops reporting glucose values and shows a 'Start Sensor' screen, which can cause users to miss critical high or low blood sugar events.
People using Dexcom ONE+ glucose monitors with app versions 1.4.0 or earlier are affected. Those with diabetes who rely on continuous glucose monitoring are most at risk.
Check for app versions 1.4.0 or earlier on Dexcom ONE+ devices. The product model number is SW14244 with lot code UDI: SW14244 - 00386270004307.
Update to the latest app version to fix the missing sensor failure alerts.
The app doesn't alert users when the sensor fails, which can lead to missed detection of high or low blood sugar events.
Dexcom ONE+ app versions 1.4.0 and earlier, and Dexcom G7 app versions 2.8.0 and earlier.
Check your app version in the Dexcom ONE+ settings; affected versions are 1.4.0 or earlier for ONE+ and 2.8.0 or earlier for G7.
We’ve drafted a message you can send Dexcom to request your refund or repair — edit it as you like.
Subject: Recall Z-2450-2025 — Dexcom Dexcom Hello, I own a Dexcom that is covered by recall Z-2450-2025 from Dexcom. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.