Agency classClass IOur severity:Severe FDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert."

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
Category: Medical Device — Continuous Glucose Monitor
Hazard: alarm-failure
missed-alert
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 →

Same manufacturer · Dexcom Inc

See all →

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High
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FDA (Devices) · 2026-05-20
High
Dexcom G7 app defect may delay glucose readings and alerts
FDA (Devices) · 2026-05-20
High
Dexcom G7 CGM iOS App Software Defect Delays Glucose Alerts
FDA (Devices) · 2026-05-20
Critical
Glucose monitoring app recalled because it can terminate and miss alerts
FDA (Devices) · 2025-11-05

Same hazard · alarm failure