Recall Z-1943-2025
Dexcom, Inc. · initiated May 12, 2025
Class I – dangerous or defective products that could cause serious health problems or death
Product
Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)
Codes / lots: All Lots/ UDI: STK-FM-001 - 00386270003232 & STK-FR-001 - 00386270003225
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1943-2025
- Initiated
- May 12, 2025
- Posted by FDA
- June 16, 2025
- Product code
- QBJ – Integrated Continuous Glucose Monitoring System, Factory Calibrated
- Quantity
- 36,824 units
- 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…
- Recalling firm
- Dexcom, Inc., San Diego, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1944-2025 Class I | Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012…Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit… | 05/12/2025Open, Classified |
| Z-1945-2025 Class I | Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013…Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit… | 05/12/2025Open, Classified |
| Z-1946-2025 Class I | Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006…Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit… | 05/12/2025Open, Classified |