Class I recallOngoing

Dexcom G6 and G7 receiver recall: missed audible glucose alerts

FDA · FDA event 96743 · Posted Jun 16, 2025

Published Jun 16, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

On May 12, 2025, Dexcom issued a "Urgent: Medical Device Correction" Notification to affected consignees via E-Mail. On June 9, 2025, Dexcom issued an Urgent: Medical Device Correction update Dexcom asked consignees to take the following actions:
1. Verify if your receiver is affected by this issue: Check the serial number for any receiver(s) you use: https://dexcom.com/en-us/checkreceiver
2. If your receiver is affected, contact Dexcom Technical Support at 1-844-478-1600 to coordinate return of the affected receiver and a no charge replacement.
3. Whether or not your receiver is affected by this notification, Dexcom continues to recommend regular testing of the speaker. Test speaker function every time you charge your receiver. When you charge, a reminder prompt will invite you to test speaker function. 4.If you need assistance related to this issue or notification, please call Dexcom Technical Support at 1- 844-478-1600. Technical Support is available 24 hours a day/7 days a week to assist you.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This record references Dexcom G6 Continuous Glucose Monitoring System and Dexcom G7 Continuous Glucose Monitoring System by Dexcom, Inc..

Products affected by FDA event 96743
Model	Description	Lot / serial range	Manufactured	Status
Z-1946-2025	Z-1946-2025	All Lots/ UDI: STK-DO-006 -00386270003188 STK-DO-013 -00386270002327 STK-DO-103-00386270002969 STK-DO-109 -00386270002792	Not provided in the normalized record	Ongoing
Z-1945-2025	Z-1945-2025	All Lots/ UDI: STK-D7-013 - 00386270003812; STK-D7-014 - 00386270003843; STK-D7-103 - 00386270003836	Not provided in the normalized record	Ongoing
Z-1944-2025	Z-1944-2025	All Lots/ UDI: STK-AT-011 - 00386270002198 STK-AT-012 -00386270002518 STK-AT-013 - 00386270002525 STK-GT-001 - 00386270004291 STK-GT-008 - 00386270004260 STK-GT-013 - 00386270002273 STK-GT-019 - 04595986293080 STK-GT-100 - 00386270002020 STK-GT-109 - 00386270002129 STK-GT-113 - 00386270003638	Not provided in the normalized record	Ongoing
Z-1943-2025	Z-1943-2025	All Lots/ UDI: STK-FM-001 - 00386270003232 & STK-FR-001 - 00386270003225	Not provided in the normalized record	Ongoing

Distribution: worldwide distribution - US Nationwide and the countries of Andorra, Argentina Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, New Zealand, Norway, Oman, Poland, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom.
Units affected: See official FDA record
Category: Continuous glucose monitors

Timeline

May 12, 2025
Recall initiated
Date recorded by the FDA.
Jun 16, 2025
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 96743
Published: Jun 16, 2025
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

Class II recallOngoing

Dexcom G7 recall: two unauthorized sensor lots

Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for…

FDA · FDA event 98968Posted Jun 24, 2026Dexcom G7 Continuous Glucose Monitoring System

Class II recallOngoing

Dexcom G7 app recall: delayed glucose readings and alerts

A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay"…

FDA · FDA event 98639Posted May 11, 2026Dexcom G7 Continuous Glucose Monitoring System

Class I recallOngoing

Dexcom G6 Android app recall: unexpected app termination

A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. This could result in the missed detection of a…

FDA · FDA event 97607Posted Oct 30, 2025Dexcom G6 Continuous Glucose Monitoring System

Loading MedWatcher information…

Dexcom G6 and G7 receiver recall: missed audible glucose alerts

FDA · FDA event 96743 · Posted Jun 16, 2025

Published Jun 16, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Affected products and models

Products affected by FDA event 96743
Model	Description	Lot / serial range	Manufactured	Status
Z-1946-2025	Z-1946-2025	All Lots/ UDI: STK-DO-006 -00386270003188 STK-DO-013 -00386270002327 STK-DO-103-00386270002969 STK-DO-109 -00386270002792	Not provided in the normalized record	Ongoing
Z-1945-2025	Z-1945-2025	All Lots/ UDI: STK-D7-013 - 00386270003812; STK-D7-014 - 00386270003843; STK-D7-103 - 00386270003836	Not provided in the normalized record	Ongoing
Z-1944-2025	Z-1944-2025	All Lots/ UDI: STK-AT-011 - 00386270002198 STK-AT-012 -00386270002518 STK-AT-013 - 00386270002525 STK-GT-001 - 00386270004291 STK-GT-008 - 00386270004260 STK-GT-013 - 00386270002273 STK-GT-019 - 04595986293080 STK-GT-100 - 00386270002020 STK-GT-109 - 00386270002129 STK-GT-113 - 00386270003638	Not provided in the normalized record	Ongoing
Z-1943-2025	Z-1943-2025	All Lots/ UDI: STK-FM-001 - 00386270003232 & STK-FR-001 - 00386270003225	Not provided in the normalized record	Ongoing

Distribution

worldwide distribution - US Nationwide and the countries of Andorra, Argentina Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, New Zealand, Norway, Oman, Poland, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom.

Units affected

See official FDA record

Dexcom G6 and G7 receiver recall: missed audible glucose alerts

Follow Dexcom G6 Continuous Glucose Monitoring System and Dexcom G7 Continuous Glucose Monitoring System

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Dexcom G6 and G7 receiver recall: missed audible glucose alerts

Follow Dexcom G6 Continuous Glucose Monitoring System and Dexcom G7 Continuous Glucose Monitoring System

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline