Agency classClass IOur severity:Critical FDA (Devices)·Z-1946-2025·Announced 2025-06-25

Dexcom One Continuous Glucose Monitoring System Receiver Speaker Defect

Dexcom, Inc. is recalling Dexcom One Continuous Glucose Monitoring System receivers due to potential defective foam or assembly errors that may cause the speaker to lose contact with internal components, resulting in missed audible alerts for dangerous blood glucose levels.

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 FDA classified this as a Class I recall. The source text explicitly states that the defect could lead to death, which is a criterion for Critical severity per the rubric.

Plain-English summary

Dexcom, Inc. is recalling the Dexcom One Continuous Glucose Monitoring System due to a defect in the receiver device. The defect involves either defective foam or an assembly error that may cause the receiver speaker to lose contact with the printed circuit board.

As a result of this defect, users may not receive audible alerts when their blood glucose levels become dangerously low (hypoglycemia) or high (hyperglycemia). Missed alerts could prevent timely treatment of these conditions.

Untreated low or high blood glucose can cause serious medical complications, including seizures, vomiting, loss of consciousness, or death. The affected devices are distributed worldwide, including in the United States and in multiple countries across Europe, Asia, the Middle East, Africa, and Oceania.

Consumers who have a recalled Dexcom One receiver should contact Dexcom, Inc. for information about device replacement or corrective action. Patients should not rely solely on the receiver's audible alerts and should continue to monitor their blood glucose levels by other means.

The recalled product

Product: Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), STK-DO-103 (MT27409-2), STK-DO-109 (MT27409-2)
Manufacturer: Dexcom, Inc.
Category: Medical Device — Continuous Glucose Monitoring System
Hazard: speaker-malfunction
missed-alerts
hypoglycemia
hyperglycemia
Affected units: 38,127

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 →

Same manufacturer · Dexcom, Inc.

See all →

Severe
Dexcom G7 Continuous Glucose Monitoring System sensors recalled
FDA (Devices) · 2026-07-01
High
Dexcom ONE+ iOS CGM App Software Defect Delayed Glucose Alerts
FDA (Devices) · 2026-05-20
High
Dexcom G7 app defect may delay glucose readings and alerts
FDA (Devices) · 2026-05-20
High
Dexcom G7 CGM iOS App Software Defect Delays Glucose Alerts
FDA (Devices) · 2026-05-20
Critical
Glucose monitoring app recalled because it can terminate and miss alerts
FDA (Devices) · 2025-11-05

Same hazard · speaker malfunction