The Recall Desk
HighFDA (Devices)·Z-1339-2016·Announced 2016-04-20

Dexcom G5 Mobile Receiver Recall for Missing Audible Alarms

Dexcom Inc is recalling 41,925 G5 Mobile Receivers because they may fail to provide intended audible alarms or alerts to users.

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 intended for diabetes management where a failure to provide audible alarms poses a risk of harm to users, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Dexcom Inc is recalling 41,925 units of the Dexcom G5 Mobile Receiver. The affected products include receivers with part numbers MT22719 (Black), MT22719-PNK (Pink), and MT22719-BLU (Blue). These devices are 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 glucose trends as intended.

The affected receivers were distributed worldwide, including in the United States (nationwide), Canada, Italy, Netherlands, Belgium, Norway, New Zealand, Poland, Sweden, Denmark, Slovenia, Turkey, South Africa, India, Israel, Hungary, Hong Kong, UK, Ireland, France, Finland, Spain, Portugal, Colombia, Chile, Germany, Austria, Switzerland, Kuwait, United Arab Emirates, Australia, Czech Republic, Bahrain, Lebanon, and Qatar. Specific lot numbers and receiver kit numbers are listed in the official recall documentation.

The recalled product

Product
Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Black; MT22719-PNK, Receiver (mg/dL), Pink; MT22719-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
Manufacturer
Dexcom Inc
Affected units
41,925

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 →