Agency classClass IOur severity:Critical FDA (Devices)·Z-2450-2025·Announced 2025-09-10

Dexcom ONE+ iOS app recalled because sensor failed alerts do not appear

The Dexcom ONE+ iOS CGM App, versions 1.4.0 and earlier, is recalled because it does not give the expected Sensor Failed alert and silently ends the session. 39,309 units are affected.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The rubric assigns 5 to any FDA Class I recall, and the FDA classified this continuous glucose monitoring app action as Class I.

Plain-English summary

The Dexcom ONE+ iOS CGM App, model SW14244, software versions 1.4.0 and earlier, UDI 00386270004307, is being recalled. The action covers Dexcom G7 Continuous Glucose Monitoring Systems using iOS, watchOS and Android app software versions 2.8.0 or earlier and Dexcom ONE+ CGM Systems using iOS and Android app software versions 1.4.0 or earlier. The recall covers 39,309 units distributed in the United States and many other countries.

The affected app does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message after the CGM experiences a hardware or firmware failure. Instead the app ends the sensor session, stops reporting glucose values and displays the Start Sensor screen or a No active sensor message without alerting the user. The manufacturer states this can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment. The FDA classified the action as Class I.

Users should update the app as directed by the manufacturer and check regularly that a sensor session is active, following their clinician's guidance on backup glucose testing.

The recalled product

Product: Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring…
Manufacturer: Dexcom, Inc.
Category: Medical Device — Glucose Monitoring
Hazard: missing-alert
software-defect
glucose-monitoring
class-i
Affected units: 39,309

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Lot Code: UDI: SW14244 - 00386270004307

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Dexcom, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · Dexcom, Inc.

See all →

Severe
Dexcom G7 Continuous Glucose Monitoring System sensors recalled
FDA (Devices) · 2026-07-01
High
Dexcom ONE+ iOS CGM App Software Defect Delayed Glucose Alerts
FDA (Devices) · 2026-05-20
High
Dexcom G7 CGM iOS App Software Defect Delays Glucose Alerts
FDA (Devices) · 2026-05-20
High
Dexcom G7 app defect may delay glucose readings and alerts
FDA (Devices) · 2026-05-20
Critical
Glucose monitoring app recalled because it can terminate and miss alerts
FDA (Devices) · 2025-11-05

Same hazard · missing alert