Home / Recalls / Dexcom, Inc. / Z-1906-2025

Z-1906-2025 Class II Ongoing

Recalled by Dexcom, Inc. — San Diego, CA

FDA device recall Z-1906-2025 was initiated by Dexcom, Inc. on May 5, 2025 and is designated Class II. 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 t… The recall status is ongoing. Affected quantity: 61,355 users.

Recall Details

Product Type
Devices
Report Date
June 11, 2025
Initiation Date
May 5, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
61,355 users

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.

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).

Code Information

Software version 2.7.0/ UDI: 00386270001863

Other recalls by Dexcom, Inc.

  • Z-2574-2026 Class II — Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom (May 27, 2026)
  • Z-2165-2026 Class II — Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexc (April 14, 2026)
  • Z-2164-2026 Class II — Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom (April 14, 2026)
  • Z-2163-2026 Class II — Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom (April 14, 2026)
  • Z-0318-2026 Class I — Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom (August 28, 2025)
  • Z-2448-2025 Class I — Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom (July 24, 2025)
  • Z-2446-2025 Class I — Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom (July 24, 2025)
  • Z-2450-2025 Class I — Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexc (July 24, 2025)
  • Z-2447-2025 Class I — Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom (July 24, 2025)
  • Z-2449-2025 Class I — Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexc (July 24, 2025)

FDA data resources