This communication is an FDA Early Alert. The FDA has become aware of a potentially high-risk issue. The FDA will keep the public informed and update this web page as significant new information becomes available.

Affected Product

The FDA is aware that Abbott Diabetes Care has issued a letter to distributors, health care providers, and affected customers recommending certain glucose monitor sensors be removed from where they are used or 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

Full list of affected lots

FreeStyle Libre 3 readers and mobile apps are not impacted. Additionally, no other Libre products (FreeStyle Libre 14 day, FreeStyle Libre 2, FreeStyle Libre 2 Plus, or Libre Pro sensors) or Abbott biowearables are impacted.

What to Do

Patients should verify if their sensors are impacted and immediately discontinue use and dispose of the affected sensor(s).

On November 24, 2025, Abbott Diabetes Care sent all affected customers a letter recommending the following actions:

• For Patients:
  • Determine if your current or unused sensor(s) are affected by visiting www.freestylecheck.comExternal Link Disclaimer and selecting “CONFIRM SENSOR SERIAL NUMBER.” You will need to locate your sensor serial number to determine if your sensor is affected.
    • If you are wearing a FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensor, you can find the serial number in the app or reader. The serial number can also be found on the label on the bottom of the sensor applicator or carton. (If you are using a sensor with a connected insulin delivery device, please refer to the connected insulin delivery device user manual on how to locate the sensor serial number.)
    • Please see images below for visual aids on where to locate the sensor serial numbers.
  • If you are currently wearing or have a FreeStyle Libre 3 or FreeStyle Libre 3 Plus sensor that has been confirmed as potentially affected on www.FreeStyleCheck.comExternal Link Disclaimer or by a customer service representative, immediately discontinue use and dispose of the affected sensor(s).
  • You can request a replacement for any potentially affected sensor(s) on www.FreeStyleCheck.comExternal Link Disclaimer. Select “CONFIRM SENSOR SERIAL NUMBER” and enter a valid serial number. If your sensor is potentially impacted, you will be instructed to enter your contact information so a replacement product can be sent to you at no cost.
  • Use a blood glucose meter or the built-in meter in your FreeStyle Libre 3 Reader to make treatment decisions when your sensor readings don’t match your symptoms or expectations.
• For Health Care Providers:
  • Inform your patients of this issue. Please instruct your patients to visit www.FreeStyleCheck.comExternal Link Disclaimer to confirm if their sensors are impacted. Abbott Diabetes Care has provided a patient letter to use with your patients.
  • If your patient is currently wearing or has a FreeStyle Libre 3 or FreeStyle Libre 3 Plus sensor that has been confirmed as potentially affected on www.FreeStyleCheck.comExternal Link Disclaimer or by a customer service representative, have them immediately discontinue use and dispose of the affected sensor(s).
  • Patients can request a replacement for any potentially affected sensor(s) on www.FreeStyleCheck.comExternal Link Disclaimer. They can select “CONFIRM SENSOR SERIAL NUMBER” and enter a valid serial number. If their sensor is potentially impacted, they will be instructed to enter their contact information so a replacement product can be sent to them at no cost.
  • Patients can use a blood glucose meter or the built-in meter in the FreeStyle Libre 3 Reader to make treatment decisions when sensor readings don’t match symptoms or expectations.
  • Your sales representative will contact you with instructions to dispose of your impacted samples. You will received sample replacements.
• For Distributors and Wholesalers:
  • Inform your customers of this Urgent Medical Device Correction and have impacted sensors returned to you under your normal return process.
  • Check your inventory for sensors from affected lots, remove them from inventory, and return them using the normal return process.

Check this web page for updates. The FDA is currently reviewing about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

How to Locate the Sensor Serial Number:

Patients wearing a FreeStyle Libre 3 sensor or a FreeStyle Libre 3 Plus sensor can find the serial number in the app or reader. The serial number can also be found on the label on the bottom of the sensor applicator or carton. (If patients are using a sensor with a connected insulin delivery device, they can refer to the connected insulin delivery device user manual on how to locate the sensor serial number.)

In the FreeStyle Libre 3 app, from the Main Menu select “About Screen” and locate the sensor serial number under “Last 3 Sensors.”

In the Libre app, from the bottom Menu select Profile > About, and locate the sensor serial number under “Last 3 Sensors.”

In the FreeStyle Libre 3 Reader, from the Settings Menu select “System Status,” then “System Info.”

Reason for Early Alert

Abbott Diabetes Care stated that certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors provide incorrect low glucose readings. If undetected, incorrect low glucose readings over an extended period may lead to wrong treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses. These decisions may pose serious health risks, including potential injury or death, or other less serious complications.

As of November 14, 2025, Abbott has reported 736 serious injuries, and seven deaths associated with this issue.

Device Use

The FreeStyle Libre 3 and FreeStyle Libre 3 Plus Continuous Glucose Monitoring Systems are real time continuous glucose monitoring (CGM) devices with alarm capability indicated for the management of diabetes in persons age four and older. These devices are intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.

The Systems also detect trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.

The Systems are also intended to autonomously communicate with digitally connected devices. The Systems can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Abbott Diabetes Care at 1-833-815-4273 or https://www.freestyle.abbott/us-en/support/contact-us.htmlExternal Link Disclaimer.

Additional Company Resources

Company-provided information is posted here by the FDA as a public service.

• Abbott Press ReleaseExternal Link Disclaimer [11/24/2025]

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

• How do I recognize a UDI on a label?
• AccessGUDID database – Identify Your Medical Device
• Benefits of a UDI System

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. source