Dexcom G7 Glucose Receiver recalled due to a Defect, United States

United States

Dexcom, Inc. has initiated a recall of its Dexcom G7 Glucose Receiver due to a defect that may cause the device's speaker to lose contact with the circuit board, potentially leading to missed alerts for blood glucose levels. A total of 1,912,306 units are affected, and the products were distributed worldwide, including the U.S., Europe, and several other countries.

The recall was initiated on May 12, 2025, and classified as a Class I recall. The defect was identified as a nonconforming material/component issue. The recall remains open as of June 16, 2025.

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.

AFFECTED PRODUCT:
- Multiple SKUs
- SKU's Number: STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0), STK-GT-008 (MT26403-5), STK-GT-013 (MT26403-1) , STK-GT-019 (MT26403-4) , STK-GT-100 (MT26403-2) , STK-GT-102 (MT26403-2) , STK-GT-109 (MT26403-2) , STK-GT-113 (MT26403-3) , STK-GT-120 (MT26403-2).
- Code Information (UDI):
STK-AT-011 - 00386270002198
STK-AT-012 - 00386270002518
STK-AT-013 - 00386270002525
STK-GT-008 - 00386270004260
STK-GT-013 - 00386270002273
STK-GT-019 - 04595986293080
STK-GT-100 - 00386270002020
STK-GT-102 - 00386270002136
STK-GT-109 - 00386270002129
STK-GT-113 - 00386270003638
STK-GT-120 - 00386270002143

If you or a loved one are harmed or experiencing any symptoms, it is important to report it. Reporting can help to detect & resolve outbreaks early and prevent others from being harmed, and enables better surveillance. If symptoms persist, seek medical care.

Source: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm