Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-D7-103 (MT28285-2)
This recall is currently active, issued June 16, 2025. It was issued by Dexcom Inc.
- Company
- Dexcom Inc
- Recall Initiated
- May 12, 2025
- Posted
- June 16, 2025
- Recall Number
- Z-1945-2025
- Quantity
- 26,291 units
- Firm Location
- San Diego, CA
- Official Source
- View on FDA website ↗
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.
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, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom.
Lot / Code Info
All Lots/ UDI: STK-D7-013 - 00386270003812; STK-D7-014 - 00386270003843; STK-D7-103 - 00386270003836
Root 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.