Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 1, 2020
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.
The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring S…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Dexcom Inc recalled Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Gluco… - a moderate-severity action.
Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Gluco… was recalled by Dexcom Inc in April 1, 2020. Reason: The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may f…. Check the official notice for the remedy. Verify recall #Z-1561-2020 with the FDA Devices before acting.
The recall
Dexcom Inc issued this moderate-severity FDA Devices recall-The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may f….
- Moderate
- severity level
- Class II
- classification
- April 1, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1561-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1561-2020) was formally reported on April 1, 2020, with the manufacturer initiating the action on February 3, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Dexcom Inc is listed as the recalling firm, operating out of San Diego, CA. Federal records list the affected scope as 85529 Systems.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: World-wide Distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
85529 Systems
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1561-2020 |
| Date reported | April 1, 2020 |
| Date initiated | February 3, 2020 |
| Recalling firm | Dexcom Inc |
| Firm location | San Diego, CA |
| Affected scope | 85529 Systems |
| Distribution | World-wide Distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1561-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Dexcom Inc. Units affected: 85529 Systems.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on April 1, 2020. Severity: Moderate. Recall number: Z-1561-2020.
Where was the recalled product distributed? ▼
Distribution: World-wide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1561-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 1, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.