Recall StatusOpen, Classified
Date Initiated2025-05-05
Product Quantity61,355 users
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.
Firm Action
On May 05, 2025, Dexcom issued a "Urgent Warning" Recall notification to affected consignees via application update. Dexcom asked consignees to take the following actions:
1. Upgrading from app version 2.7 is mandatory and app version 2.7 is no longer available for use.
2. If you need assistance, contact Technical Support. Local Tech Support contact information is available at Dexcom.com
Please note that US customers should utilize one of the following options for support.
" Phone - 1-844-478-1600
" Call Back request Call Back Request Form
" Web Form - https://dexcom.custhelp.com/app/webform
" Live chat - https://dexcom.custhelp.com/app/chat/chat_avail
If you have any questions, call 858-200-0200 or email:
[email protected].
Root Cause
Software design
Distribution Pattern
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), Hong Kong (HK), Ireland (IE), Israel (IL), Iceland (IS), Italy (IT), Jordan (JO), Korea, Repulic (KR), Kuwait (KW), Lebanon (LB), Lithuania (LT), Luxemburg (LU), Malta (MT), Netherlands (NL), Norway (NO), New Zealand (NZ), Oman (OM), Poland (PL), Portugal (PT), Qatar (QA), Saudi Arabia (SA), Sweden (SE), Slovenia (SI), Slovakia (SK), Turkey (TR) and South Africa (ZA).
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.