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FDA Recalls Certain FreeStyle Libre 3 and Libre 3 Plus Sensors

Vetted by Stefan Rest 3 min read

Abbott is removing certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors. The FDA says they may show glucose readings that are lower than a person’s actual level. The FDA has identified this as the most serious type of recall. Only certain sensors are involved. The readers and apps are not. This recall is also different from an earlier Libre 3 recall in 2024. Here is what to know and how to check a sensor.

Which part is affected

A continuous glucose monitor, or CGM, uses a small sensor worn on the body. The sensor tracks glucose through the day and sends readings to a reader or phone app. This recall is about certain sensors only.

The FDA lists these sensor models:

  • FreeStyle Libre 3 sensor, model numbers 72081-01 and 72080-01
  • FreeStyle Libre 3 Plus sensor, model numbers 78768-01 and 78769-01

Not every sensor with these model numbers is affected. The way to know is to check the serial number, as explained below.

The FDA says FreeStyle Libre 3 readers and mobile apps are not affected. It also says FreeStyle Libre 14 day, FreeStyle Libre 2, FreeStyle Libre 2 Plus and Libre Pro sensors are not part of this recall.

Why low readings matter

A reading that is too low could make a person think their blood sugar is lower than it really is. The FDA says that could lead to wrong treatment choices, such as eating too many carbohydrates or skipping or delaying an insulin dose. It says those choices could lead to serious health risks, including injury or death.

The FDA says that as of January 7, 2026, Abbott had reported 860 serious injuries and seven deaths associated with this issue. These are reports. They do not prove the sensor caused each event, and the numbers may have changed since that date.

Key dates

  • November 24, 2025: Abbott sent a letter to affected customers.
  • December 2025: The FDA posted an early alert about the problem.
  • February 4, 2026: The FDA classified the recall as Class I, its most serious type.

How to check a sensor

The FDA gives these steps:

  • Find the sensor’s serial number. In the FreeStyle Libre 3 app, go to Main Menu, then About, then Last 3 Sensors. In the Libre app, go to Profile, then About. On a reader, go to Settings, then System Status, then System Info. The number is also on the label on the bottom of the sensor applicator or carton.
  • Enter the serial number on Abbott’s checking site, freestylecheck.com, under “Confirm Sensor Serial Number.”
  • If a sensor is affected, stop using it right away and throw it away. Abbott will send a free replacement through the same site.
  • If sensor readings do not match your symptoms or what you expect, use a blood glucose meter or the reader’s built-in meter before making treatment decisions.

Abbott’s customer line for this recall is 1-833-815-4273. Talk with your health care provider about any symptoms or concerns.

Not the same as the 2024 Libre 3 recall

In 2024, Abbott recalled a small number of FreeStyle Libre 3 sensors for a different problem. Those sensors, from three lots, could give readings that were incorrectly high. The FDA reported two injuries and no deaths for that recall. Abbott sent its notice in July 2024.

The 2026 recall is about readings that may be too low, and it covers more sensors. Checking a sensor for one recall does not answer the question for the other. Use the checking steps for the recall you are looking at.

What about lawsuits?

As of September 27, 2026, we have not found a public settlement or jury verdict involving this recall in the federal court records we reviewed. A recall does not, by itself, prove that a sensor caused a person’s injury. Whether someone has a claim depends on the facts, the records and the law that applies. No result can be promised.

This sensor recall is one of several recent glucose monitor notices. Our Glucose Monitor Recall page explains how sensors, receivers, apps and meters differ, and where to find the FDA notice for each one.

This article is general information about how these cases work. It is not legal advice, it does not create an attorney-client relationship, and no two claims are alike. If something here sounds like your situation, the useful next step is a conversation about the facts.

Sources and citations

Statutes, regulations, agency material and decisions referred to above.

  1. Glucose Monitor Sensor Recall: Abbott Diabetes Care Removes Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus SensorsU.S. Food and Drug AdministrationContent current as of February 5, 2026; checked September 27, 2026. Source of the affected models, the low-reading risk, the injury and death count as of January 7, 2026, the products not affected, the dates and the checking steps.
  2. Continuous Glucose Monitoring (CGM) Sensor Recall: Abbott Diabetes Care, Inc. Issues Recall for Certain FreeStyle Libre 3 SensorsU.S. Food and Drug AdministrationContent current as of September 5, 2024. Source of the separate 2024 recall for incorrectly high readings.
  3. FreeStyle Libre Sensor CheckAbbott Diabetes CareThe manufacturer’s serial number checking tool named in the FDA notice, cited only as the place to check a sensor.

Vetted by

Stefan Rest, managing director of CBW Law

Stefan Rest

Managing Director, CBW Law

Stefan Rest has spent more than two decades advocating for consumers and helping people understand how the law may provide a path forward when they’ve been wronged. As Managing Director of CBW Law, he oversees client relations, the firm’s national law-firm network and new partnerships. He writes about developing litigation and consumer legal issues because the right information can help people recognize when their own story may matter.

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