Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Recalled by Dexcom Inc Due to The company identified potential interference from hydroxyurea. Patient...

Date: February 3, 2020
Company: Dexcom Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Dexcom Inc directly.

Affected Products

Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.

Quantity: 85529 Systems

Why Was This Recalled?

The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems.

Where Was This Sold?

World-wide Distribution

About Dexcom Inc

Dexcom Inc has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report