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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Monitoring Devices

Dexcom Glucose Receivers Recalled for Defective Speaker Alerts

Agency Publication Date: June 16, 2025
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Summary

Dexcom, Inc. is recalling approximately 703,687 Dexcom G6, G7, and Dexcom One glucose monitoring receivers because a defect in the speaker assembly may cause them to fail. These devices are used to track blood sugar levels and sound an alert when values are dangerously high or low. If the speaker loses contact with the circuit board, patients may not hear these critical alarms, preventing them from treating blood sugar issues in time. This recall affects receivers distributed across the United States and multiple other countries.

Risk

A failed speaker prevents the device from sounding audible alarms for high or low blood glucose levels. This can lead to untreated hypoglycemia or hyperglycemia, which can result in serious health complications including seizures, vomiting, loss of consciousness, or death.

What You Should Do

  1. This recall affects Dexcom G6, G7, Dexcom One+, and Dexcom One Continuous Glucose Monitoring System receivers.
  2. Check your device's packaging or label for SKU (Part Number) and UDI codes including STK-FM-001, STK-AT-011, STK-D7-013, or STK-DO-006. See the Affected Products section below for the full list of affected codes.
  3. Stop using the product. Return it to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or Dexcom, Inc. for further instructions.
  4. For further information, call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider, or return the product to the place of purchase for a refund or replacement
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Stop using and throw the product away.

Affected Products

Product: Dexcom G6 Glucose Receiver
Model / REF:
STK-FM-001 (MT27408-1)
STK-FR-001 (MT27408-1)
UDI:
00386270003232
00386270003225

Recall #: Z-1943-2025; Quantity: 36,824 units

Product: Dexcom G7 Glucose Receiver
Model / REF:
STK-AT-011 (MT26403-0)
STK-AT-012 (MT26403-0)
STK-AT-013 (MT26403-0)
STK-GT-001 (MT26403-1)
STK-GT-008 (MT26403-5)
STK-GT-013 (MT26403-1)
STK-GT-019 (MT26403-4)
STK-GT-100 (MT26403-2)
STK-GT-109 (MT26403-2)
STK-GT-113 (MT26403-3)
UDI:
00386270002198
00386270002518
00386270002525
00386270004291
00386270004260
00386270002273
04595986293080
00386270002020
00386270002129
00386270003638

Recall #: Z-1944-2025; Quantity: 602,445 units

Product: Dexcom One+ Continuous Glucose Monitoring System
Model / REF:
STK-D7-013 (MT28285-1)
STK-D7-014 (MT28285-1)
STK-D7-103 (MT28285-2)
UDI:
00386270003812
00386270003843
00386270003836

Recall #: Z-1945-2025; Quantity: 26,291 units

Product: Dexcom One Continuous Glucose Monitoring System
Model / REF:
STK-DO-006 (MT27409-1)
STK-DO-013 (MT27409-1)
STK-DO-103 (MT27409-2)
STK-DO-109 (MT27409-2)
UDI:
00386270003188
00386270002327
00386270002969
00386270002792

Recall #: Z-1946-2025; Quantity: 38,127 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96743
Status: Active
Manufacturer: Dexcom, Inc.
Sold By: Authorized Medical Distributors; Pharmacies
Manufactured In: United States
Units Affected: 4 products (36,824 units; 602,445 units; 26,291 units; 38,127 units)
Distributed To: Nationwide
Agency Last Updated: August 19, 2025

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.