Dexcom G7 Glucose Receiver recalled due to defective foam or assembly error
Dexcom, Inc. is recalling Dexcom G7 Glucose Receiver units due to defective foam or assembly error that may cause the speaker to lose contact with the circuit board, preventing audible alerts for low or high blood glucose.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This recall is classified as FDA Class I and the source text explicitly identifies death as a potential consequence of the defect, meeting the Critical threshold per the rubric.
Plain-English summary
Dexcom, Inc. is recalling 602,445 units of the Dexcom G7 Glucose Receiver. The recalled devices are distributed worldwide, including throughout the US and 41 other countries.
The defect may cause the receiver speaker to lose contact with the printed circuit board due to defective foam or an assembly error. This could result in missed audible alerts for low or high blood glucose values.
Missed alerts for dangerous blood glucose levels could lead to untreated hypoglycemia or hyperglycemia. These conditions can cause seizures, vomiting, loss of consciousness, or death.
Affected customers should contact Dexcom, Inc. for instructions on obtaining a replacement device. The affected models include SKUs STK-AT-011, STK-AT-012, STK-AT-013, STK-GT-001, STK-GT-008, STK-GT-013, STK-GT-019, STK-GT-100, STK-GT-109, and STK-GT-113.
The recalled product
- Product
- Dexcom G7 Glucose Receiver, SKUs (part number): 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 (
- Manufacturer
- Dexcom, Inc.
- Hazard
- speaker-contact-loss
- missed-alerts
- hypoglycemia
- hyperglycemia
Distribution
Distributed nationwide across the United States.
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