Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM… — Class II medical device recall Z-1562-2020
Terminated recall by Dexcom Inc, reported 2020-04-01. The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may fa
| Recall number | Z-1562-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dexcom Inc, San Diego, CA, United States |
| Recall initiated | 2020-02-03 |
| Classified | 2020-03-25 |
| Reported by FDA | 2020-04-01 |
| Terminated | 2022-01-20 |
| Quantity | 275,583 |
| UPC / GTIN / UDI-DI | 00386270000866, 00386270001047, 50386270000250, 70386270000254 |
| Model numbers | STS-OE-003, STS-OM-003, STS-OR-003 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1562-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.