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

FDA Device Recall #Z-1906-2025 — Class II — May 5, 2025

Recall Summary

Recall Number Z-1906-2025
Classification Class II — Moderate risk
Date Initiated May 5, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Dexcom, Inc.
Location San Diego, CA
Product Type Devices
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).

Lot / Code Information

Software version 2.7.0/ UDI: 00386270001863

Other Recalls from Dexcom, Inc.

Recall # Classification Product Date
Z-0318-2026 Class I Brand Name: Dexcom G6 Continuous Glucose Monito... Aug 28, 2025
Z-2447-2025 Class I Brand Name: Dexcom G7 Continuous Glucose Monito... Jul 24, 2025
Z-2448-2025 Class I Brand Name: Dexcom G7 Continuous Glucose Monito... Jul 24, 2025
Z-2450-2025 Class I Brand Name: Dexcom ONE+ Continuous Glucose Moni... Jul 24, 2025
Z-2449-2025 Class I Brand Name: Dexcom ONE+ Continuous Glucose Moni... Jul 24, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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