FDA Medical Device Recalls (openFDA)
Dexcom, Inc.: Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system
- Recall number
- Z-1906-2025
- Recalling firm
- Dexcom, Inc.
- Product
- Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system
- Status
- Open, Classified
- Initiated
- 2025-05-05
- Posted
- 2025-06-04
- Terminated
- not on file
- 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.
- 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: Charles.boykin@dexcom.com.
- Quantity
- 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).
- Lot, serial or model codes
- Software version 2.7.0/ UDI: 00386270001863
- 510(k) numbers
- ["K231081"]
- PMA numbers
- not on file
- Product code
- QBJ
- Firm FEI
- 3004753838
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28