Dexcom, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1906-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 5, 2025

Date Posted: June 11, 2025

Recall Number: Z-1906-2025

Event ID: 96684

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.

Status: Ongoing

Product Quantity: 61,355 users

Code Information:

Software version 2.7.0/ UDI: 00386270001863

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).

Voluntary or Mandated:

Voluntary: Firm initiated