Dexcom: Urgent Medical Correction June 2025
URGENT: Dexcom G6 and G7 Receiver Safety Notice
Date: June 2025
Important Safety Information for Dexcom Receiver Users
We have received an urgent medical device correction notice from Dexcom regarding certain G6 and G7 receivers that may not provide audio alerts as designed. We are required to inform all customers who may have purchased these products.
AFFECTED PRODUCTS
- Part Number: MT27408-1
- SKUs: STK-FM-001, STK-FR-001
- Part Number: MT26403-0
- SKUs: STK-AT-011, STK-AT-012, STK-AT-013
THE ISSUE
Affected receivers may not produce audio sounds for glucose alerts and alarms. The receivers will continue to provide vibration alerts and visual notifications. All glucose readings remain accurate.
IMMEDIATE ACTION REQUIRED
-
Check if your receiver is affected:
- Visit: https://dexcom.com/en-us/checkreceiver
- Enter your receiver serial number (located on back of device)
- If affected, call Dexcom at 1-844-478-1600 for free replacement
-
Test your speaker function regularly:
- Test each time you charge your receiver
- Manual test: Menu → Information → Receiver → Speaker → Test
- If test fails, contact Dexcom immediately
SAFETY RISK
Missing audio alerts could result in delayed detection of severe hypoglycemia or hyperglycemia. As of May 2025, there have been 112 global complaints and 56 reports of severe adverse events potentially related to this issue. All patients recovered.
CONTACT INFORMATION
Dexcom Technical Support (24/7): 1-844-478-1600
FDA Adverse Event Reporting: www.fda.gov/medwatch/report.htm
FULL DOCUMENTATION
View the complete Urgent Medical Device Correction Notice with all technical details, lot numbers, and comprehensive safety information:
Download Full Safety Notice (PDF)This notice is required by the FDA and Dexcom Quality Compliance.