FDA Device recall Z-2165-2026
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software V…
- FDA Device
- Class II
- ongoing
- Published 2026-05-20
On 2026-05-20 the FDA classified a Class II recall of Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software V… by Dexcom, citing A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the ap….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2165-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-14 |
| Published | 2026-05-20 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Dexcom |
| Distribution | US |
Product
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System
Reason
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
Identifiers
| code_info | Lot Code: SW14244 versions 1.5.0 and 1.6.0 - UDI-DI: 00386270004307 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2165-2026%22
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