The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2163-2026·Announced 2026-05-20

Dexcom G7 CGM iOS App Software Defect Delays Glucose Alerts

Dexcom, Inc. is recalling versions 2.9.0 through 2.11.2 of the Dexcom G7 Continuous Glucose Monitoring iOS app due to a software defect that delays glucose value notifications and alerts, risking missed detection of dangerous blood sugar events.

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: This is a Class II medical device recall involving a software defect that delays critical health alerts (glucose values) used for real-time diabetes management decisions. No illnesses or injuries are reported in the source text; however, the risk of missing hypoglycemic or hyperglycemic events in a life-critical monitoring device qualifies as a risk-of-harm product where the hazard is not merely theoretical (the mechanism and consequences are clearly described), meeting the High severity threshold.

Plain-English summary

Dexcom, Inc. is recalling versions 2.9.0 through 2.11.2 of the Dexcom G7 Continuous Glucose Monitoring (CGM) iOS app (Model SW12300) due to a software defect. A low-priority file input/output 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 and then replay sequentially when the user reopens the app, causing the Glucose Compass to flicker through previous glucose readings. In more severe cases, the app may incorrectly perceive signal loss and activate signal loss mitigations, further delaying glucose information delivery.

This delay in EGV and alert processing creates a risk that users may miss detection of hypoglycemic (low blood sugar) or hyperglycemic (high blood sugar) events, or make treatment decisions based on outdated glucose information. The affected software versions were distributed worldwide, including throughout the United States and multiple countries internationally.

Dexcom has issued approximately 58,582 units of the affected software. Users should update their Dexcom G7 iOS app to a version newer than 2.11.2. For additional information, contact Dexcom or consult the FDA recall notice.

The recalled product

Product
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System…
Manufacturer
Dexcom, Inc.
Category
Medical Device — Continuous Glucose Monitoring System
Hazard
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: SW12300 versions 2.9.0 through 2.11.2 - UDI-DI: 00386270001863

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 →

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