Recall Z-1906-2025— Dexcom, Inc.

Name: FDA recall Z-1906-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-05

Class II · Ongoing

Class II FDA medical device recall by Dexcom, Inc., initiated 2025-05-05. It names one FDA 510(k) clearance: K231081. Product: Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system. Reason: A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are not being updated and that glucose alerts will not trigger, there is potential for the missed detection of a hyperglycemic or hypoglycemic event or a treatment decision made based off incorrect data. There is no impact to transmitter communication with concurrently connected displays. A concurrently connected receiver, Apple Watch, and/or insulin pump will continue to receive EGVs directly from the transmitter when the app is in the problematic state. There is no impact to Automated Insulin Dosing (AID) therapy as the AID system continues to receive EGVs directly from the transmitter..

Recalling firm: Dexcom, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-05-05
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K231081 — Dexcom G7 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.·cleared 2023-05-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system

Reason for recall

A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are not being updated and that glucose alerts will not trigger, there is potential for the missed detection of a hyperglycemic or hypoglycemic event or a treatment decision made based off incorrect data. There is no impact to transmitter communication with concurrently connected displays. A concurrently connected receiver, Apple Watch, and/or insulin pump will continue to receive EGVs directly from the transmitter when the app is in the problematic state. There is no impact to Automated Insulin Dosing (AID) therapy as the AID system continues to receive EGVs directly from the transmitter.

Data sourced from openFDA. This site is unofficial and independent of the FDA.