Class II recallOngoing

Dexcom G6 receiver recall: delayed glucose alerts

FDA · FDA event 96091 · Posted Feb 20, 2025

Published Feb 20, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net error occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a subsequent alarm/alert is triggered. At that time, the initial alarm/alert is delivered, but not the second one. Alarm/alerts will continue to be delayed and be one alarm/alert behind, causing delayed alarm/alerts until the receiver is reset. This condition could result in the missed detection of a hyperglycemic or hypoglycemic event. Second, a single EGV reading may be delayed for 5 minutes after the initial .net operating system error. If the user receives a single EGV reading delayed by 5 minutes, the delay is not expected to cause user harm.

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 January 27, 2025, Dexcom issued a "Urgent: Medical Device Correction to affected consignees via E-Mail. Dexcom asked consignees to take the following actions:
If available, use the G6 App as primary display device to receive glucose readings and alerts. The G6 transmitter allows simultaneous communication with an iOS or Android device as well as a receiver (see letter for additional details).
If using an affected G6 Receiver, check CGM glucose values and glucose trend regularly as CGM glucose values and glucose trend graph information continue to be displayed
If you believe you may be experiencing the missed or delayed alarm/alerts issue, the issue can be corrected by shutting down the receiver and then turning it back on.
Please navigate to the following webpage: https://www.dexcom.com/g6-receiver-update
Please read the information provided on the webpage and any recommended actions regarding a software update for your receiver to permanently resolve this issue.

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 by Dexcom, Inc..

Products affected by FDA event 96091
Model	Description	Lot / serial range	Manufactured	Status
Z-1204-2025	Z-1204-2025	All Serial Numbers/UDI: 00386270001900	Not provided in the normalized record	Ongoing
Z-1203-2025	Z-1203-2025	All Serial Numbers/UDI: 00386270000590	Not provided in the normalized record	Ongoing
Z-1202-2025	Z-1202-2025	All Serial Numbers/UDI: 00386270000583	Not provided in the normalized record	Ongoing

Distribution: Worldwide - US Nationwide distribution in the states of OH, TX, PA, MN, SC, NH, FL, CA, NJ, PR, GA and the countries of Austria, Belgium, Canada, Switzerland, Germany, Spain, France, Ireland, Japan, Netherlands, Slovenia, United Kingdom, Australia, Czech Republic, Denmark, Finland, France, Hong Kong, Israel, Italy, Korea, Kuwait, New Zealand, Norway, Oman, Poland, Qatar, Saudi Arabia, Singapore, Slovakia, South Africa, Sweden, Turkey, United Arab Emirates.
Units affected: See official FDA record
Category: Continuous glucose monitors

Timeline

Jan 27, 2025
Recall initiated
Date recorded by the FDA.
Feb 20, 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: 96091
Published: Feb 20, 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

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Loading MedWatcher information…

Dexcom G6 receiver recall: delayed glucose alerts

FDA · FDA event 96091 · Posted Feb 20, 2025

Published Feb 20, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Affected products and models

Products affected by FDA event 96091
Model	Description	Lot / serial range	Manufactured	Status
Z-1204-2025	Z-1204-2025	All Serial Numbers/UDI: 00386270001900	Not provided in the normalized record	Ongoing
Z-1203-2025	Z-1203-2025	All Serial Numbers/UDI: 00386270000590	Not provided in the normalized record	Ongoing
Z-1202-2025	Z-1202-2025	All Serial Numbers/UDI: 00386270000583	Not provided in the normalized record	Ongoing

Distribution

Worldwide - US Nationwide distribution in the states of OH, TX, PA, MN, SC, NH, FL, CA, NJ, PR, GA and the countries of Austria, Belgium, Canada, Switzerland, Germany, Spain, France, Ireland, Japan, Netherlands, Slovenia, United Kingdom, Australia, Czech Republic, Denmark, Finland, France, Hong Kong, Israel, Italy, Korea, Kuwait, New Zealand, Norway, Oman, Poland, Qatar, Saudi Arabia, Singapore, Slovakia, South Africa, Sweden, Turkey, United Arab Emirates.

Units affected

See official FDA record

Dexcom G6 Android app recall: unexpected app termination

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

Class I recallOngoing

Dexcom G6 and G7 receiver recall: missed audible glucose alerts

FDA · FDA event 96743Posted Jun 16, 2025Dexcom G6 Continuous Glucose Monitoring System,Dexcom G7 Continuous Glucose Monitoring System

Dexcom G6 receiver recall: delayed glucose alerts

Follow Dexcom G6 Continuous Glucose Monitoring System

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Dexcom G6 receiver recall: delayed glucose alerts

Follow Dexcom G6 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