FDA Device recall Z-2164-2026
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 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 G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 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-2164-2026 |
| 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 G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone app and the versions used are the same for each user. The watchOS app cannot be installed independently from the iOS phone app. Component: Dexcom G7 Continuous Glucose Monitoring System, Dexcom G7 15 Day 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a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.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: SW13355 versions 2.9.0 through 2.11.2 - UDI-DI: 00386270005168 |
|---|
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-2164-2026%22
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