Dexcom, Inc. recalls Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) syst…

Recall date

May 5, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1906-2025

FDA classification

Class II

Brand / firm

Dexcom, Inc.

Sold / distributed

Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: United Arab Emirates (AE), Austria (AT), Australia (AU), Belgium (BE), Bahrain (BH), Canada (CA), Switzerland (CH), Czech Republic (CZ), Germany (DE), Denmark (DK), Spain (ES), Finland (FI), France (FR), United Kingdom (GB),…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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