CLASS II Device recall · Reported 1 Apr 2020 · FDA Enforcement Report
G5 Continuous Glucose Monitoring System The Dexcom G4 recalled
Dexcom is recalling Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 Platinum Continuous Glucose. The recall was initiated on 3 Feb 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1561-2020
- FDA event ID
- 84891
- Recalling firm
- Dexcom, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Feb 2020
- FDA classified
- 25 Mar 2020
- Reported
- 1 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Foreign Material
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 3 Feb 2020 | Recall initiated by company | |
| 25 Mar 2020 | Classified by FDA | +51 days |
| 1 Apr 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
World-wide Distribution
Questions about this recall
Is G5 Continuous Glucose Monitoring System The Dexcom G4 Platinum Continuous Glucose recalled?
Yes. Dexcom recalled G5 Continuous Glucose Monitoring System The Dexcom G4 Platinum Continuous Glucose on 3 Feb 2020. The recall is Class II and its status is Terminated. Recall number Z-1561-2020.
Why was it 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.
Which lots are affected?
Device Listing Number: D189069 Model: STS-GL-041 Description: G4/G5 Sensor Kit 4 Pack GUDID Registered GTIN: 30386270000010 Lot Number: All Model: STS-RX-041 Description: G4/G5 Sensor Kit 4 Pack Retail GUDID Registered GTIN: 20386270000013 Lot Number: All Model: STS-MC-004 Description: G4/G5 Sensor Kit 4 Pack Medicare GUDID Registered GTIN: 00386270000637 Lot Number: All
Where was it sold?
World-wide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Insulin Pumps & Glucose Monitors recalls
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|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Lead & Heavy Metals | Nationwide |