Worldwide Recall of FreeStyle Libre 3 and FreeStyle Libre 3 Plus Glucose Sensors Due to Health Risks

On December 2, 2025, the U.S. Food and Drug Administration (FDA) issued an FDA Early Alert informing the public that Abbott Diabetes Care Inc., an integral division of global healthcare giant Abbott, is recalling certain model numbers of the FreeStyle Libre 3 Sensor and the FreeStyle Libre 3 Plus Sensor glucose monitors.

Abbot advised patients and distributors to discontinue use and dispose of the faulty sensors immediately. The sensors were reporting erroneously low glucose readings, and Abbott reported that 700+ users of these sensors may have experienced serious health issues because of the inaccurate readings  – which also may have been the cause of seven deaths.

If you were hospitalized for injuries associated with highly elevated glucose levels that were mistakenly monitored by a FreeStyle Libre 3 or FreeStyle Libre 3 Plus Sensor, contact us today or call 1-866-900-7078. You may be eligible for significant compensation.

What Does a Glucose Monitor Do and How Can Inaccurate Readings Impact You?

Glucose monitors measure the amount of sugar (glucose) in your blood and help people with diabetes manage their condition by showing how food, exercise, and medication affect their blood sugar levels.

The FreeStyle Libre 3 Sensor and FreeStyle Libre 3 Plus Sensor are both Continuous Glucose Monitoring (CGM) systems that are implanted under the skin to provide 24/7 glucose readings without finger sticks. As of November 14, 2025, Abbott had internally tracked and reported 736 serious injuries and seven deaths allegedly linked to inaccurate readings of the FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors.

While glucose monitors are intended to track sugar levels and prevent unhealthy fluctuations in blood sugar, they pose considerable risk to those trying to keep their blood sugar in a target range when they provide inaccurate readings.

If incorrect low blood sugar readings are not noticed for a long time, people with diabetes may make the wrong treatment choices, such as eating too much sugar or skipping or delaying insulin. These mistakes can cause serious health problems, including injury or even death, as well as other complications.

You may have many questions about your case. For a no-cost, no-obligation case evaluation, call 1-866-900-7078 today. We are here to help.

What Health Risks Are Associated With the FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors?

Users of malfunctioning glucose monitors who receive erroneous low readings may be hospitalized for injuries resulting from highly elevated glucose levels, such as:

• Hyperglycemia
• Diabetic Ketoacidosis (build-up of toxic acids in the blood due to lack of insulin)
• Hyperosmolar Hyperglycemic State (combination of high blood sugar levels and dehydration which can lead to a coma)
• Long-term Organ Damage, including to the eyes, kidneys, nerves, and heart
• Coma
• Death

Important Dates and Facts About the Recall

Significant dates for the recall of the FreeStyle Libre 3 Sensor and the FreeStyle Libre 3 Plus Sensor include:

• December 2, 2025 – FDA issues an FDA Early Alert on the Glucose Monitor Sensor Issue from Abbott Diabetes Care
• November 24, 2025 – Abbott Diabetes Care sent a recall notice of multiple lots of monitors due to potentially incorrect glucose readings to all affected customers recommending immediate discontinuation of use of the impacted monitors.
• November 24, 2025 – Abbott distributed a press release informing the public that it had initiated medical device correction (recall) for certain models of FreeStyle Libre 3 Sensor and FreeStyle Libre 3 Plus Sensor in the U.S.
• Mid-November, 2025 – Abbott reports the emerging issues with the FreeStyle Libre 3 and FreeStyle Libre 3 Plus to the FDA.

What Models of the FreeStyle Libre 3 Sensor and FreeStyle Libre 3 Plus Sensor Have Been Recalled?

In the 11/24/25 recall letter sent to distributors, health care providers, and affected customers, Abbott Diabetes Care recommended that the following glucose monitor sensors should not be used and should also be removed immediately from where they are sold:

• FreeStyle Libre 3 Sensor
  • Model Numbers: 72081-01, 72080-01
  • Unique Device Identifiers (UDI-DI): 00357599818005, 00357599819002
• FreeStyle Libre 3 Plus Sensor
  • Model Numbers: 78768-01, 78769-01
  • Unique Device Identifiers (UDI-DI): 00357599844011, 00357599843014

For more information and a full list of affected lots, visit the FDA Early Alert site on this recall.

Where Are the Malfunctioning FreeStyle Libre 3 Sensors and Freestyle Libre 3 Plus Sensors Located?

In Abbott’s November 24, 2025 press release, the company stated that none of the seven deaths and 57 of the 736 adverse health events associated with the sensors occurred in the U.S. The company also informed the public that it had initiated a medical device correction (recall) in the U.S. involving approximately 3 million Libre 3 Sensors and Libre 3 Plus Sensors – about half of which are estimated to have expired or been used.

To determine if your current or unused sensor(s) are affected, the FDA Early Alert recommends that you visit www.freestylecheck.com and select “CONFIRM SENSOR SERIAL NUMBER.”

Are You Eligible for Compensation From Abbott?

If you, or a loved one, used a non-expired FreeStyle Libre 3 Sensor or FreeStyle Libre 3 Plus Sensor and were hospitalized for injuries resulting from elevated glucose levels as described above, on or after June 2022, you may be eligible for compensation for:

• Medical expenses
• Lost wages
• Emotional and physical pain and suffering
• Other damages

But don’t delay in having an experienced personal injury attorney review your case! If you wait, you may miss out on your opportunity for compensation and to hold Abbott accountable for its malfunctioning product.

Personal Injury Lawyers Can Evaluate Your FreeStyle Libre 3 Sensor or FreeStyle Libre 3 Plus Sensor Claim – Free

If you used a defective FreeStyle Libre 3 Sensor or FreeStyle Libre 3 Plus Sensor and were hospitalized with injuries associated with high glucose levels, you may be entitled to significant compensation for your injuries.

We know how to help you decide on the next right step for you. We’ve helped many clients who were harmed by defective medical products, such as:

• Philips CPAP, BiPAP, and Ventilator Devices
• Bard PowerPort Catheters
• Hip Implants
• Exactech replacement joints
• Surgical Staplers
• Surgical Mesh

Our team is available 24/7/365, so call today for a free and confidential evaluation of your case. You can also use our live chat feature or submit our secure and confidential form on the bottom of this page. It typically takes just a few minutes to provide us the information we need to determine if you may have a case.

Call the Law Offices of James Scott Farrin today at 1-866-900-7078 to find out how we may be able to help you.

The Law Offices of James Scott Farrin consults with a national network of attorneys on product liability, defective drugs, and defective products cases in an attempt to provide the best representation we can for our clients. Depending on the details of your case, our firm will likely refer your matter to another law firm with which we associate. We will only do this if we believe it is in your best interests and if you agree.