Dexcom One+ Continuous Glucose Monitoring System Receiver Speaker Defect
Dexcom, Inc. is recalling 26,291 units of the Dexcom One+ Continuous Glucose Monitoring System due to defective foam or assembly errors that may prevent audible alerts for low or high blood glucose levels, potentially leading to seizures, loss of consciousness, or death.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The recall is FDA Class I, the highest regulatory classification, and the source text explicitly identifies potential fatal outcomes (death, seizures, loss of consciousness) from missed audible alerts. This meets the Critical threshold per the rubric.
Plain-English summary
Dexcom, Inc. is recalling 26,291 units of the Dexcom One+ Continuous Glucose Monitoring System (SKU Part Numbers STK-D7-013, STK-D7-014, and STK-D7-103) worldwide, including distribution across the United States and 35 other countries.
A defective foam or assembly error may cause the receiver speaker to lose contact with the printed circuit board. This defect can result in missed audible alerts that notify users of low or high blood glucose values.
Missed audible alerts could lead to untreated low or high blood glucose episodes (hypoglycemia or hyperglycemia), which may cause seizures, vomiting, loss of consciousness, or death.
Consumers who have received one of these devices should contact Dexcom, Inc. for guidance on obtaining a replacement or repair to ensure the device functions properly.
The recalled product
- Product
- Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-D7-103 (MT28285-2)
- Manufacturer
- Dexcom, Inc.
- Affected units
- 26,291
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- All Lots/ UDI: STK-D7-013 - 00386270003812
- STK-D7-014 - 00386270003843
- STK-D7-103 - 00386270003836
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Dexcom, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Dexcom, Inc.
See all →- SevereDexcom G7 Continuous Glucose Monitoring System sensors recalled
FDA (Devices) · 2026-07-01
- HighDexcom ONE+ iOS CGM App Software Defect Delayed Glucose Alerts
FDA (Devices) · 2026-05-20
- HighDexcom G7 app defect may delay glucose readings and alerts
FDA (Devices) · 2026-05-20
- HighDexcom G7 CGM iOS App Software Defect Delays Glucose Alerts
FDA (Devices) · 2026-05-20
- CriticalGlucose monitoring app recalled because it can terminate and miss alerts
FDA (Devices) · 2025-11-05
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- SevereDexcom G4 Platinum Receiver Recall for Missing Audible Alarms
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