Z-1906-2025Class II

Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring...

Name: Z-1906-2025 Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring...
Creator: Dexcom, Inc.
Published: 2025-05-05
License: https://open.fda.gov/license/

Dexcom, Inc. / initiated 2025-05-05 / Open, Classified / root cause: software

FDA source

Dexcom, Inc. began a recall of Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system on 2025-05-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1906-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-05
Posted: 2025-06-04
Recalling firm: Dexcom, Inc.
Product: Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system
Product code: QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
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.
Root cause tag: software
FDA root cause: Software design
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].
Quantity in commerce: 61,355 users
Distribution: 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).
Product codes and lots: Software version 2.7.0/ UDI: 00386270001863

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1906-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1906-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-11	2025-06-04

Product code QBJ

K231081Class IIDexcom G7 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. / cleared 2023-05-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)