Z-1202-2025Class II

Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001

Name: Z-1202-2025 Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001
Creator: Dexcom, Inc.
Published: 2025-01-27
License: https://open.fda.gov/license/

Dexcom, Inc. / initiated 2025-01-27 / Open, Classified / root cause: software

FDA source

Dexcom, Inc. began a recall of Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001 on 2025-01-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1202-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-27
Posted: 2025-02-20
Recalling firm: Dexcom, Inc.
Product: Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001
Product code: QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
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.
Product codes and lots: All Serial Numbers/UDI: 00386270000583

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1202-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1202-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20
Z-1203-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20
Z-1204-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20

Product code QBJ

K223931Class IIDexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc. / cleared 2023-01-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)