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U.S. Department of Health and Human Services

Class 1 Device Recall Dexcom One Glucose Receiver

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 Class 1 Device Recall Dexcom One Glucose Receiversee related information
Date Initiated by FirmMay 12, 2025
Date PostedJune 16, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1945-2025
Recall Event ID 96743
Product Classification Integrated Continuous Glucose Monitoring system, factory calibrated - Product Code QBJ
ProductDexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-D7-103 (MT28285-2)
Code Information UDI: STK-D7-013 - 00386270003812; STK-D7-014 - 00386270003843; STK-D7-103 - 00386270003836
Recalling Firm/
Manufacturer		 Dexcom, Inc.
6340 Sequence Dr
San Diego CA 92121-4356
For Additional Information ContactDexcom Technical Support
1844-478-1600
Manufacturer 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 2		Nonconforming Material/Component
ActionOn 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.
Quantity in Commerce26,291 units
Distributionworldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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