By Rafsana Writu
The U.S. FDA announced an immediate recall for FreeStyle Libre Glucose monitors. The FDA has categorized this issue as a Class I recall, indicating a severe risk of injury or death from continued use of the affected sensors.
Today, many diabetes patients depend on continuous glucose monitoring (CGM) to track blood sugar levels easily throughout the day. FreeStyle Libre Sensors is one of the most famous sensors used, including the FreeStyle Libre 3 and Libre 3 Plus sensors.1 They are designed to continuously measure glucose just under the skin and send that information to a reader or smartphone app so users and caregivers can make informed treatment decisions.
However, in late 2025 and into early 2026, there have been significant safety alerts and device corrections affecting millions of these sensors in the United States.
What Potential Injuries Are There With FreeStyle Libre Sensors
In November 2025, Abbott announced that some FreeStyle Libre 3 and Libre 3 Plus sensors displayed falsely low glucose readings, potentially leading to incorrect treatment decisions for diabetics, such as excessive sugar intake or inappropriate insulin dosages.2
This could result in significant health risks, including:
- Hypoglycemia or Hyperglycemia (improper sugar levels).
- Death.
- Central nervous system dysfunction.
- Loss of consciousness or coma.
- Seizures.
- Permanent neurological damage.
The Extent of the Issue
- Close to 3 million Libre 3 and Libre 3 Plus sensors sold in the U.S. are potentially affected.
- There are several issues and seven deaths worldwide potentially connected to flawed sensors.
- The problem is a result of manufacturing issues that affect a specific production line, though the company says it has identified and resolved them.
Abbott is still producing and distributing new sensors and other FreeStyle Libre products, unaffected by the recent correction. Inaccurate glucose readings from these devices can significantly impact daily management for individuals with type 1 or type 2 diabetes, influencing medication dosing, dietary choices, and overall health safety, which is a significant concern for both medical professionals and regulators.3
Steps to Consider When Taking a Legal Action
Step 1. Document Everything
Collect all the records about the sensor used:
- The name of the sensor you used, including the serial numbers and model
- When and how it provided readings.
- Any symptoms or health problems that followed.
- Medical records showing treatment or injuries received.
- Including photos, screenshots, and emails with Abbott or healthcare providers can also be helpful.
2. Check the FDA and Manufacturer Information
3. Seek Medical Evaluation
Consult with your doctor and confirm whether the device’s inaccurate readings had medical consequences that affected you. If positive, the doctor’s professional notes and records can support a claim by showing how the defect impacted your health.
4. Consult a Lawyer Experienced in Product Liability
Product liability law covers injuries from defective products, including medical devices. Lawyers in this field can help determine whether:
- Your situation qualifies for a lawsuit.
- Claims should be filed in state or federal court.
- There are existing class-action lawsuits you might join.
5. Consider Your Options
Depending on your case, a lawyer might suggest:
- You file a standalone lawsuit if your injuries are significant and clearly linked to the defective sensor.
- You join a class-action or multi-district litigation (MDL) if many people are suing over the same issue.
- You negotiate a settlement with Abbott or its insurers.
The recent alert on the FreeStyle Libre sensor shows the critical role of dependable medical devices for diabetes management. Affected users should verify their sensors, stop usage if needed, and obtain a free replacement.4 Those experiencing health issues due to inaccurate readings from faulty devices may want to consult with an attorney to consider potential legal action.
Sources
1 Abbott, Abbott. 2026. “Abbott Initiates Medical Device Correction for Certain FreeStyle Libre® 3 and FreeStyle Libre 3 plus Sensors in the U.S.” U.S. Food and Drug Administration. 2026. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-initiates-medical-device-correction-certain-freestyle-librer-3-and-freestyle-libre-3-plus.
2 “Home | FreeStyle – Abbott.” 2025. Freestylecheck.com. 2025.
3 Jensch, Hendrick, Steven Setford, Nicole Thomé, Geethan Srikanthamoorthy, Lea Weingärtner, Mike Grady, Elizabeth Holt, and Andreas Pfützner. “Dynamic Interference Testing—Unexpected Results Obtained with the Abbott Libre 2 and Dexcom G6 Continuous Glucose Monitoring Devices.
4 Herman, Jessica L., Jonathan A. Lidbury, Genna F. Atiee, Shannon E. Washburn, and Carly A. Patterson. “The FreeStyle Libre 2 system demonstrates limited analytical accuracy without resulting in detrimental clinical decisions.” American Journal of Veterinary Research 86, no. 8 (2025).