In November 2025, global healthcare company Abbott initiated a medical device correction for certain lots of their FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors. According to the press release, a manufacturing issue may cause devices to provide “incorrect low glucose readings.”
The US Food and Drug Administration (FDA) later classified this as a Class I recall (the most serious type), indicating that continued use of the affected devices may cause serious injury or death. As of January 7, 2026, Abbott has reported 860 serious injuries and 7 deaths associated with this issue, according to the FDA’s recall notice. These figures may understate the full scope of harm, as recent reporting from NBC News found that some adverse events associated with recalled lot numbers have not been included in Abbott's official count.
FreeStyle Libre 3 users are encouraged to check the serial number of their device to determine if it was affected by the medical device correction. Patients relying on the FreeStyle Libre 3 are encouraged to use a blood glucose meter for treatment decisions if sensor readings do not match symptoms or expectations.
At Wisner Baum, we can explain the FreeStyle Libre 3 recall and whether legal action is possible against the manufacturer.
Abbott Diabetes Care recalled multiple lots of the FreeStyle Libre 3 and FreeStyle Libre 3 Plus after the company identified a manufacturing issue that may cause some sensors to provide glucose readings that are lower than actual blood glucose levels. The recall involves approximately 3 million sensors distributed in the U.S. The FDA has classified this as a Class I recall—the most serious type.
Abbott reported 860 serious injuries and 7 deaths associated with this issue as of January 7, 2026. Just over two weeks later, the FDA issued a warning letter to Abbott, citing quality system violations at its Alameda, California manufacturing facility. FDA inspectors found that Abbott released finished FreeStyle Libre CGM devices without testing them for accuracy after final assembly and sterilization, and that Abbott’s responses to the agency’s concerns were inadequate.
This is not the first FreeStyle Libre 3 recall. In July 2024, Abbott recalled certain lots for the opposite problem—falsely high glucose readings—which the FDA also classified as Class I.
Using a recalled FreeStyle Libre 3 can have serious consequences. According to the FDA, if incorrect low glucose readings go undetected, they may lead to wrong treatment decisions, such as excessive carbohydrate intake or skipping or delaying insulin doses.
Health risks related to inaccurate glucose readings:
According to the Abbott press release and FDA Early Alert, the potential manufacturing issue which causes the devices to output an incorrect glucose reading affects both the FreeStyle Libre 3 and the FreeStyle Libre 3 Plus sensors. Individuals concerned that they may have a defective device are encouraged to visit FreeStyle Check. If your device was impacted, it is recommended that you stop using it immediately and use a backup blood glucose monitoring system for treatment decisions.
Affected devices in the FreeStyle Libre 3 and FreeStyle Libre 3 Plus recall:
Patients using a FreeStyle Libre 3 or FreeStyle Libre 3 Plus Sensor are encouraged to check the manufacturer’s website to determine if their device was impacted by the recall. Affected devices may be eligible for replacement, although it can take a substantial amount of time to receive a new device. Individuals should use a backup method to test blood glucose levels and ensure prompt and proper treatment.
Steps to check if your FreeStyle Libre 3 sensor was included in the recall:
Individuals using a FreeStyle Libre 3 or FreeStyle Libre 3 Plus device are encouraged to check the FDA recall database for additional announcements regarding the sensors and monitor Abbott’s website for press releases about the affected devices.
It is important to discuss any changes to monitoring with a licensed healthcare provider and to report missed alerts immediately. If a reading does not match symptoms or expectations, a backup monitoring system should be used before making treatment decisions.
Inaccurate blood glucose monitoring sensors could result in a lawsuit against the manufacturer. Patients who rely on the devices to make diabetes treatment decisions may be entitled to damages, including compensation for medical bills, lost wages, and pain and suffering.
In order to hold manufacturers accountable for a defective or dangerous device, patients should document any medical outcomes or financial losses potentially related to the recalled sensor. While not every recall results in litigation, individuals who suffer harm as a result of a company’s negligence or wrongdoing may be able to take legal action.
The attorneys with Wisner Baum have an extensive history representing individuals affected by dangerous or defective medical devices. Our medical device attorneys have significant experience investigating product liability claims and holding manufacturers accountable when the facts support legal action.
Is FreeStyle Libre 3 on recall?
In November 2025, Abbott Diabetes Care issued a medical device correction for several lots of its FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors after internal testing determined that some sensors may provide incorrect low glucose readings. The FDA has since classified this as a Class I recall—the most serious type. As of January 7, 2026, Abbott has reported 860 serious injuries and 7 deaths associated with this issue.
What are the risks of using a Libre 3?
Using a faulty Libre 3 sensor to make diabetes treatment decisions may result in seizures, vomiting, loss of consciousness, hypoglycemic or hyperglycemic symptoms, or even death.
How do I report a faulty Libre 3 sensor?
Individuals can report a faulty Libre 3 sensor through Abbott’s website at www.freestylecheck.com and should report any adverse effects from using the device to the FDA’s MedWatch program.
Can a faulty Libre sensor be replaced?
Abbott is providing a replacement for affected Libre sensors, but it could take a significant amount of time to receive. The company notes that there is high demand for replacements and patients should expect a delay.
Has the Libre 3 been discontinued?
The FreeStyle Libre 3 and FreeStyle Libre 3 Plus have not been discontinued. Abbott has stated that it identified and resolved the manufacturing issue and continues to produce sensors to fulfill replacement and new orders.
How do I know if my Libre 3 sensor is bad?
The best way to determine if your Libre 3 sensor is faulty or was affected by the recall is to enter in the sensor serial number at www.freestylecheck.com.
Can the Libre 3 give false readings?
According to Abbott and the FDA, certain lots of the FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors may provide glucose readings that are lower than actual blood glucose levels due to a manufacturing issue that Abbott has identified.
