The Recall Desk
HighFDA (Devices)·Z-1337-2016·Announced 2016-04-20

Dexcom G4 Platinum Receiver Recall for Missing Audible Alarms

Dexcom Inc is recalling G4 PLATINUM Receivers with Share 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 is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The failure of audible alarms in a diabetes monitoring device poses a significant risk of harm.

Plain-English summary

Dexcom Inc is recalling the Dexcom G4 PLATINUM Receiver with Share. The affected units 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 is being issued because customers may not receive an intended audible alarm or alert if they are relying on hearing the alarm or alert. This defect could prevent users from being notified of critical glucose readings through sound.

The recall involves 53,106 units that were distributed worldwide, including the United States, Canada, and numerous countries in Europe, Asia, Africa, and the Middle East. Consumers who have this product should check their Receiver Kit Number and Lot Number against the official list to determine if their device is affected.

The recalled product

Product
Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
Manufacturer
Dexcom Inc
Affected units
53,106

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 →