The Recall Desk
SevereFDA (Devices)·Z-2448-2025·Announced 2025-09-10

Dexcom G7 and ONE+ glucose monitor apps fail to alert on sensor failure

Dexcom G7 and ONE+ app versions fail to alert users when the glucose sensor fails. Without alerting, they stop reporting glucose values, which can delay detection of dangerous blood sugar levels and treatment.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification applies. Although no illnesses or injuries have been reported, the defect can lead to missed detection of dangerous blood sugar levels (hypoglycemia/hyperglycemia) and delayed medical treatment.

Plain-English summary

Dexcom is recalling versions 2.8.0 and earlier of the Dexcom G7 Continuous Glucose Monitoring System app (iOS, watchOS, Android) and versions 1.4.0 and earlier of the Dexcom ONE+ app (iOS, Android). The recall affects devices distributed worldwide, including throughout the United States.

When a glucose sensor experiences a hardware or firmware failure, the app should alert the user. Instead, the affected app versions silently end the monitoring session, stop reporting glucose values, and display only a generic message like "Start Sensor" or "No active sensor" without notifying the user that the sensor has failed.

This silent failure prevents users from detecting that their glucose monitoring has stopped. It can delay detection of dangerously high (hyperglycemic) or low (hypoglycemic) blood sugar levels and delay necessary medical treatment. Consumers using the affected app versions should contact Dexcom for guidance on updating to a corrected version.

The recalled product

Product
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: versions 2.8.0 and earlier Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone
Manufacturer
Dexcom, Inc.
Category
Medical Device — Continuous Glucose Monitor
Hazard
  • alert-failure
  • monitoring-failure
  • missed-glucose-event-detection

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 - SW1355- 00386270005168

Distribution

Distributed nationwide across the United States.

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