The Recall Desk
HighFDA (Devices)·Z-1335-2016·Announced 2016-04-20

Dexcom G4 Platinum Pediatric Receiver Recall for Missing Audible Alarms

Dexcom Inc is recalling 18,004 G4 Platinum Pediatric Receivers because they may fail to provide intended audible alarms or alerts.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where the failure to provide audible alarms poses a risk of harm to users with diabetes, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Dexcom Inc is recalling 18,004 units of the Dexcom G4 PLATINUM (Pediatric) Receiver. The affected devices are identified by specific receiver kit numbers and lot numbers listed in the official recall documentation. The product is intended to detect trends and track glucose patterns in persons with diabetes.

The recall was initiated because customers may not receive an intended audible alarm or alert if they are relying on hearing the alarm or alert. This defect could compromise the device's ability to notify users of glucose trends through sound.

The affected units were distributed worldwide, including in the United States, Canada, and numerous countries in Europe, Asia, Africa, and the Middle East. Consumers who have these specific receivers should check their lot and kit numbers against the recall list and contact Dexcom Inc for further instructions.

The recalled product

Product
Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with d
Manufacturer
Dexcom Inc
Affected units
18,004

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 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 6 products in this recall →