Agency classClass IOur severity:Severe FDA (Devices)·Z-1943-2025·Announced 2025-06-25

Dexcom G6 Glucose Receiver recalled for missed audible alerts

Dexcom G6 Glucose Receiver units may have defective foam or assembly errors that disable audible alerts for dangerously low or high blood glucose, risking 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I medical device recall. The defect can prevent critical audible alerts in a continuous glucose monitoring system, risking seizures, loss of consciousness, and death from untreated hypo- or hyperglycemia—potential serious injury outcomes that meet the Severe criterion.

Plain-English summary

Dexcom, Inc. is recalling the Dexcom G6 Glucose Receiver (SKUs STK-FM-001 and STK-FR-001, approximately 36,824 units worldwide) due to a manufacturing defect. Defective foam or assembly errors may cause the receiver speaker to lose contact with the printed circuit board, preventing audible alerts when blood glucose levels become dangerously low or high.

A missed audible alert for low or high blood glucose could lead to untreated hypoglycemia or hyperglycemia, which can cause seizures, vomiting, loss of consciousness, or death. Affected units have been distributed nationwide in the United States and in 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, and the United Kingdom.

Patients using an affected receiver should contact Dexcom, Inc. for replacement or further guidance. Healthcare providers and patients should verify whether their device is part of this recall by checking the SKU and lot information.

The recalled product

Product: Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)
Manufacturer: Dexcom, Inc.
Category: Medical Device — Glucose Monitor / Continuous Glucose Monitoring
Hazard: device-malfunction
missed-alert
hypoglycemia-risk
hyperglycemia-risk
Affected units: 36,824

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 (1)

All Lots/ UDI: STK-FM-001 - 00386270003232 & STK-FR-001 - 00386270003225

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 →

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High
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Critical
Glucose monitoring app recalled because it can terminate and miss alerts
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Same hazard · device malfunction