Recall Z-1943-2025 ยท QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
Dexcom, Inc.
Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)
| Date | Jun 16, 2025 (initiated May 12, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 b |
| 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, M |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223931 | Dexcom G6 Continuous Glucose Monitoring (CGM) System Dexcom, Inc., Jan 11, 2023 |