Dexcom G6 Continuous Glucose Monitoring System Recalled for Hydroxyurea Interference
Dexcom Inc is recalling G6 Continuous Glucose Monitoring Systems because the anti-neoplastic drug hydroxyurea may cause falsely elevated glucose readings.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 II and involves a risk-of-harm product where inaccurate readings could lead to improper medical management, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Dexcom Inc is recalling the Dexcom G6 Continuous Glucose Monitoring System. The recall involves 275,583 units of the G6 Sensor Kit, including 3-pack configurations for retail, Medicare, and Pro Q distribution. The products were distributed worldwide.
The company identified potential interference from the anti-neoplastic drug hydroxyurea. Patient use of this medication may cause the Continuous Glucose Monitoring Systems to display falsely elevated glucose readings. This issue affects persons age 18 and older with diabetes who use the device to detect trends and track patterns.
Consumers should stop using the affected devices if they are taking hydroxyurea. Dexcom Inc is the recalling firm responsible for this action.
The recalled product
- Product
- Dexcom G6 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.
- Manufacturer
- Dexcom Inc
- Affected units
- 275,583
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 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 3 products in this recall →Related recalls
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Similar recalls
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FDA (Devices) · 2025-11-05
- SevereDexcom G4 PLATINUM Receiver Recall for Missing Audible Alarms
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- SevereDexcom G4 Platinum Pediatric Receiver Recall for Missing Audible Alarms
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- HighDexcom G5 Mobile Receiver Recalled for Software Glitches
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