Case type Defective Medical Devices

Glucose Monitor Recall

Glucose monitors help people track blood sugar and make decisions about diabetes care. Some use a test strip and a small blood sample. Others use a wearable sensor to track glucose throughout the day. Recalls have affected different parts of these systems, including certain sensors, receivers, apps, and meters. This page explains how the devices work and helps you find information about specific recalls.

Looking for one device? Explore the specific recalls. If you or someone in your family experienced serious harm after a possible glucose monitor problem, CBW Law wants to hear what happened. Tell Us Your Story.

A glucose monitor can provide information people use every day. Depending on the device, it may show a current reading, track changes over time, or warn when glucose reaches a concerning level.

A problem with a reading, alert, or error message can have serious consequences. But a recall of one sensor, receiver, app version, or meter does not mean every product in that brand’s lineup is affected.

The U.S. Food and Drug Administration has issued notices involving certain Abbott FreeStyle Libre products, Dexcom products, and TRUE METRIX blood glucose meters. Each notice identifies its own affected products and recommended steps4567.

Use the links below to learn about a specific recall. If you or someone in your family experienced serious harm after a possible glucose monitor problem, CBW Law wants to hear what happened. Tell Us Your Story.

Explore Specific Glucose Monitor Recalls

Different recalls affect different devices. Choose the product or component you use to see the affected models, dates, FDA guidance, and information about a possible claim.

  • Abbott FreeStyle Libre 3 and Libre 3 Plus Sensor Recall

    Product
    Abbott FreeStyle Libre 3 and FreeStyle Libre 3 Plus
    Affected part
    Certain sensors
    The problem
    Certain affected sensors may give readings lower than actual blood glucose4.
    Dates
    Abbott wrote to customers on November 24, 2025. The FDA posted an early alert in December 2025 and its recall notice in February 20264.

    Summary only. Our full page on this recall is not ready yet. The FDA notice lists the affected sensors and the steps to take.

    Read the FDA notice on Libre 3 sensors (opens in a new tab)

  • Dexcom G6, G7, ONE and ONE+ Receiver Recall

    Product
    Dexcom G6, G7, ONE and ONE+ receivers
    Affected part
    Certain receivers
    The problem
    A speaker problem may prevent an audible alert for dangerous glucose levels5.
    Dates
    Dexcom sent an updated customer notice on June 9, 2025. The FDA posted its notice in July 20255.

    Summary only. Our full page on this recall is not ready yet. The FDA notice lists the affected receivers and the steps to take.

    Read the FDA notice on Dexcom receivers (opens in a new tab)

  • Dexcom G7 and ONE+ App Correction

    Product
    Dexcom G7 and Dexcom ONE+ apps
    Affected part
    Certain app versions
    The problem
    A software problem may prevent the expected alert when a sensor fails6.
    Dates
    Dexcom sent a customer notice on July 24, 2025. The FDA posted its notice in September 20256.

    Summary only. Our full page on this correction is not ready yet. The FDA notice lists the affected app versions and the steps to take.

    Read the FDA notice on Dexcom apps (opens in a new tab)

  • TRUE METRIX Blood Glucose Monitor Recall

    Product
    TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO and TRUE METRIX PRO, including store-brand versions
    Affected part
    Blood glucose monitoring systems and their E-5 error instructions
    The problem
    An E-5 message can mean either a test strip error or a reading above 600 mg/dL8.
    Dates
    Trividia Health began the correction on February 6, 2026. The FDA issued a safety communication on April 28, 2026, and updated it on May 19, 202678.

    Go to the TRUE METRIX recall page

How Do Glucose Monitors Work?

There are two main kinds of glucose monitors. They work in different ways.

Blood Glucose Meters

A person places a small blood sample on a compatible test strip and inserts or uses the strip with the meter. The meter displays a result for that test1. It shows blood sugar at that one moment.

Continuous Glucose Monitors (CGMs)

A wearable sensor measures glucose in fluid beneath the skin throughout the day2. A compatible app or receiver displays readings and trends. Depending on the system, it may provide alerts for high or low glucose2.

A CGM sensor, receiver, and app have different jobs:

  • The sensor is worn on the body and measures glucose.
  • The receiver is a small handheld device that shows readings and can sound alerts.
  • The app runs on a phone or watch and can also show readings and alerts.

A recall may affect only one of those parts. Some systems also connect with other devices used in diabetes care, such as insulin pumps2. That makes it especially important to follow the instructions for the exact product and component.

Why Might a Glucose Monitor Be Recalled?

A glucose monitor may be recalled for different kinds of problems. Each recall involves its own issue. No single recalled product has all of these problems. Examples include:

  • Readings that are higher or lower than actual glucose
  • Alerts that do not sound or appear as expected
  • A sensor that stops reporting data
  • A software problem
  • An unclear error message
  • A labeling or instruction problem

Recalls also differ in what they ask people to do. The FDA says a recall can be a removal, which takes a device out of use, or a correction, which fixes a problem where the device is used3. Some recalls call for replacing affected devices. Others involve a software update or new instructions.

Always follow the current FDA notice for your specific product. Do not use advice written for one device on a different one.

What Can Go Wrong With a Glucose Monitor?

A person may rely on a glucose reading or alert to recognize blood sugar that is too high or too low. An inaccurate reading, missed alert, loss of data, or confusing error message may affect what happens next.

Different FDA recalls describe different problems. You can compare them in the specific recall summaries above. A potential lawsuit would require an individual review of the product, what the device displayed, the person’s symptoms and treatment, and the harm that followed.

A recall does not, by itself, prove that a device caused an injury or that its manufacturer is legally responsible.

Which Glucose Monitor Products Have Recall Notices?

The four recalls on this page involve different companies and different parts of a device. Each one covers only certain products.

Four recalls, four different parts

Abbott sensors
Certain FreeStyle Libre 3 and Libre 3 Plus sensors may read lower than actual glucose. The FDA says the readers and apps are not affected4. Read the FDA notice on Libre 3 sensors.
Dexcom receivers
Certain G6, G7, ONE and ONE+ receivers may have a speaker problem that keeps an alert from sounding5. Read the FDA notice on Dexcom receivers.
Dexcom apps
Older versions of the G7 and ONE+ apps may not give the expected alert when a sensor fails. Dexcom fixed this with an app update6. Read the FDA notice on Dexcom apps.
TRUE METRIX meters
Four TRUE METRIX blood glucose meters, including store-brand versions, use one E-5 message for two different problems8. Learn about the TRUE METRIX meter recall.

Exact models, lot and serial numbers, and app versions are listed in each FDA notice and on our individual recall pages, not here.

Some of these products have been part of other recalls too. For example, the FDA posted a separate 2024 recall of certain FreeStyle Libre 3 sensors that could give incorrectly high readings9. That is a different problem from the 2026 recall of sensors that may read low.

The FDA’s list of medical device recalls also includes other glucose-related notices. Examples are a 2025 correction for one Dexcom G6 app version for Android11 and a 2026 correction for certain first aid kits that contain TRUE METRIX meters12. This page does not cover every notice, so check the FDA list for the device you use.

How Can I Identify My Device?

A brand name alone does not tell you whether your device is affected. Most recalls cover only certain models, lots, serial numbers, or app versions. To find out, gather the details below and compare them with the current FDA or manufacturer instructions for that specific recall.

  • Brand and product name: Look on the device, the box, or the label.
  • Model number: This is usually printed on the device, the box, or the label on the back.
  • Serial or lot number: Look on the device label, the box, or a sensor applicator or carton. Some readers and apps show a serial number in their settings or “About” screen.
  • App version: Check your phone’s app store or the app’s settings or “About” screen.
  • Where you got it: A pharmacy record, receipt, or order history can help if you no longer have the box.

Then follow the checking steps in the FDA notice for that recall or on its individual recall page. Some notices point to a checking tool on the manufacturer’s website. If you are still unsure, contact the manufacturer, your pharmacist, or your health care provider.

Should You Speak With a Glucose Monitor Recall Attorney?

CBW Law wants to hear from people who experienced serious harm after a possible problem with a glucose monitor.

That may involve:

  • A reading that appeared inaccurate
  • An alert that did not sound or appear
  • A sensor that stopped reporting data
  • A concerning error message
  • A delay in recognizing high or low blood sugar
  • Emergency treatment or hospitalization following the event

We may ask which device was used, when the event occurred, what appeared on the display, what symptoms followed, and what treatment was needed.

You do not need to know the exact model number or have every record before you contact CBW Law. Tell us what you remember.

Using a recalled product does not, by itself, mean there is a claim. What happened needs to be reviewed first.

What Information May Help Review a Glucose Monitor Claim?

Useful information may include:

  • The device and its packaging
  • Sensor applicators or cartons
  • Model, serial, lot, or product numbers
  • App name and version
  • Screenshots of readings, errors, or alerts
  • Glucose logs or readings from another device
  • Recall or replacement notices
  • Communications with the manufacturer or a health care provider
  • Emergency, hospital, and follow-up records
  • Information about medication or treatment decisions

You can contact CBW Law even if you no longer have the device or all of these records.

Never delay medical care to gather evidence. If you or someone else has signs of very high or very low blood sugar, get medical help first.

How May a Glucose Monitor Claim Move Forward?

The process begins with listening to what happened.

CBW Law may then work to identify the product and find out whether a particular FDA recall applies. Device information and medical records may help show the timing of readings, alerts, symptoms, treatment, and the alleged harm.

Attorneys can then assess whether further investigation is appropriate based on the facts and the law that applies. The law can vary from state to state.

Is There a Glucose Monitor Recall Settlement?

There is no single settlement covering all glucose monitor recalls. These notices involve different products, companies, components, and events.

Individual lawsuits have been filed in federal court about some of these products. As of September 27, 2026, we have not found a public settlement or jury verdict involving these four recalls in the federal court records we reviewed.

Another case’s outcome would not predict yours. CBW Law cannot promise a settlement amount or result.

Plain English

Understanding Glucose Monitor Recall Terms

Recall notices and doctor visits can be full of new words. Here is what some of them mean, in plain English.

The devices

Blood Glucose Meter
A device that tests a small blood sample placed on a compatible strip.
Continuous Glucose Monitor (CGM)
A system that uses a wearable sensor to track glucose over time.
Sensor
The part of a CGM that measures glucose.
Receiver
A device that displays CGM readings and may provide alerts.

Blood sugar

Hyperglycemia
Blood sugar that is too high.
Hypoglycemia
Blood sugar that is too low.

Recalls

Class I Recall
The FDA’s most serious recall classification.
Medical Device Correction
An action taken to address a device problem. It does not always require removing every device from use.

Educational only. These are plain-language summaries, not medical definitions and not medical or legal advice. Ask your doctor or pharmacist what any of these words mean for you.

Questions

Glucose Monitor Recall Frequently Asked Questions

The questions patients ask first, answered in plain English.

Are all glucose monitors being recalled?

No. Each notice identifies specific products, components, models, lots, serial numbers, or app versions. Check the notice for the device you use.

What is the difference between a blood glucose meter and a CGM?

A blood glucose meter tests a blood sample placed on a strip. A CGM uses a wearable sensor to track glucose over time and displays the information through a compatible app or receiver.

Does a sensor recall also mean the receiver or app is recalled?

Not necessarily. A recall may involve only one part of a system. Read the FDA notice for the exact product and issue.

How do I know if my device is affected?

Find your product name and identifying information, then use the checking instructions in its FDA notice or the linked individual recall page.

What should I do if my reading does not match how I feel?

Follow the instructions for your device and the FDA notice that applies to it. Contact a health care professional about symptoms or concerns. If symptoms are severe, get emergency care.

What if I no longer have the device?

You can still tell CBW Law what you remember. Purchase, pharmacy, manufacturer, app, or medical records may help identify it.

Does a recall mean I have a lawsuit?

No. A potential claim depends on the device, the event, the harm, the records, and the law that applies.

How much is a glucose monitor lawsuit worth?

There is no standard amount. CBW Law cannot promise compensation or a particular outcome.

Talk to CBW Law About a Glucose Monitor Injury

It may be difficult to tell whether a recall applies to the monitor you use. You may know that a reading seemed wrong, an alert never sounded, or an error appeared without knowing which part of the system was involved.

If a possible glucose monitor problem was followed by serious harm, tell us what happened. We can start with the information you have today.

Tell Us Your Story

This page is general information about glucose monitor recalls. It is not legal or medical advice, and reading it does not create an attorney-client relationship. Do not change how you test or treat diabetes based on this page. Follow the current FDA notice for your device and talk with your health care provider or pharmacist. The FDA’s findings are not the same as allegations in a lawsuit, and a manufacturer may dispute any claim. No lawyer can promise a result or a settlement.

Attorney advertising. The content of this website may be considered attorney advertising under the rules of certain jurisdictions. The information on this website is for general information purposes only and should not be taken as legal advice for any individual case or situation. Viewing this site does not create an attorney-client relationship. Prior results do not guarantee a similar outcome. Statutes, regulations and case law change, and the law differs from state to state.