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FDA · FDA event 98639 · Posted May 11, 2026
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a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.
| Model | Description | Lot / serial range | Manufactured | Status |
|---|---|---|---|---|
| Z-2165-2026 · SW14244 · versions 1.5.0 and 1.6.0 | Dexcom ONE+ iOS CGM App | Lot Code: SW14244 versions 1.5.0 and 1.6.0 - UDI-DI: 00386270004307 | Not provided in the normalized record | Ongoing |
| Z-2164-2026 · SW13355 · Versions 2.9.0 through 2.11.2 | Dexcom G7 CGM watchOS App | Lot Code: SW13355 versions 2.9.0 through 2.11.2 - UDI-DI: 00386270005168 | Not provided in the normalized record | Ongoing |
| Z-2163-2026 · SW12300 · Versions 2.9.0 through 2.11.2 | Dexcom G7 CGM iOS App | Lot Code: SW12300 versions 2.9.0 through 2.11.2 - UDI-DI: 00386270001863 | Not provided in the normalized record | Ongoing |
Apr 14, 2026
Recall initiated
Date recorded by the FDA.
May 11, 2026
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.