Agency classClass IIOur severity:High FDA (Devices)·Z-2164-2026·Announced 2026-05-20

Dexcom G7 app defect may delay glucose readings and alerts

Dexcom G7 CGM iOS and watchOS app versions 2.9.0 through 2.11.2 are being corrected because a software defect can delay glucose value and alert processing.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II correction where delayed glucose values and alerts could cause a missed hypoglycemic or hyperglycemic event, a risk of harm with no injuries reported.

Plain-English summary

The Dexcom G7 Continuous Glucose Monitoring System watchOS app, model SW13355, software versions 2.9.0 through 2.11.2, is subject to correction, along with the corresponding iOS app SW12300. The action covers 58,582 units.

The issue is 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 runs 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 readings. In more severe instances the app may perceive signal loss and deploy signal loss mitigations. According to the manufacturer, 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a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.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 FDA classified the action as Class II.

Distribution was worldwide. The apps are used by people managing diabetes.

Users should check their app version and follow the update instructions issued by Dexcom. Anyone unsure about a reading should confirm with a fingerstick test in line with their care plan.

The recalled product

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…
Manufacturer: Dexcom, Inc.
Category: Medical Device — Continuous glucose monitor app
Hazard: software-defect
delayed-alerts
glucose-monitoring
class-ii
missed-event
Affected units: 58,582

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Lot Code: SW13355 versions 2.9.0 through 2.11.2 - UDI-DI: 00386270005168

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Dexcom, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Dexcom, Inc.

See all →

Severe
Dexcom G7 Continuous Glucose Monitoring System sensors recalled
FDA (Devices) · 2026-07-01
High
Dexcom ONE+ iOS CGM App Software Defect Delayed Glucose Alerts
FDA (Devices) · 2026-05-20
High
Dexcom G7 CGM iOS App Software Defect Delays Glucose Alerts
FDA (Devices) · 2026-05-20
Critical
Glucose monitoring app recalled because it can terminate and miss alerts
FDA (Devices) · 2025-11-05
Critical
Dexcom G7 watchOS app recalled because sensor failure alerts are missing
FDA (Devices) · 2025-09-10

Same hazard · software defect