In late 2025, health authorities and Abbott Diabetes Care issued a warning involving some of the widely used FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring (CGM) sensors. These devices are designed to help people living with diabetes monitor blood sugar levels in real-time — often eliminating the need for routine fingerstick measurements.
What Happened?
Abbott identified manufacturing defects in specific lots of its Freestyle Libre 3 and Libre 3 Plus sensors that can result in inaccurate glucose readings. Health According to the FDA communication, Abbott advised distributors, healthcare providers, and affected customers that specific lots of FreeStyle Libre 3 and FreeStyle Libre 3 Plus CGM sensors may provide incorrect low glucose readings. These readings can be misleading to users and potentially result in improper treatment decisions, such as unnecessary carbohydrate intake or delayed insulin dosing. Patients are urged to verify whether their sensor is part of the affected lots and to discontinue use immediately if so.
The alert outlined concrete steps for patients and providers: check the sensor serial number on www.freestylecheck.com, stop using any confirmed affected sensors, dispose of them safely, and request a free replacement from Abbott. Abbott also recommends relying on a standard blood glucose meter or the built-in reader if the CGM readings don’t match symptoms or expectations.
Reported Harms and Scope of the Issue
- Abbott has reported hundreds of serious adverse events and multiple deaths potentially linked to the defective sensors.
- In the U.S., dozens of severe injuries have been documented by users of these devices.
- The recall affects millions of sensors, with thousands still in circulation.
Patients are strongly advised to stop using affected sensors immediately, confirm whether their device is part of the recalled lot using the serial number tool provided by Abbott, and switch to alternative monitoring methods if needed.
Why Accurate Glucose Monitoring Matters
Continuous glucose monitoring systems transform diabetes management, giving people trend data and alarms for high and low glucose events. Clinical research supports that accurate CGM can help reduce harmful glucose excursions and guide safe treatment adjustments.
However, studies also show that inaccurate glucose readings can lead to erroneous treatment decisions, particularly in insulin dosing, where over- or under-treatment of glucose levels can have serious medical consequences.
Medical literature on CGM accuracy highlights how incorrect readings even small deviations can result in inappropriate clinical responses, underscoring why reliable measurement technology is critical for patient safety.
Medical Device Recalls Explained
When a device like a glucose monitor is found to pose a serious health risk, the FDA can require a recall or correction to minimize that risk. Devices that potentially cause severe injury or death typically trigger the most urgent type of medical device action.
Manufacturers and users are both responsible for reporting significant adverse events to the FDA’s MedWatch system, helping regulators track and respond to emerging safety threats.
Legal and Safety Implications for Patients
For people in the Hudson Valley and beyond, the Abbott sensor issue is more than a news headline — it directly concerns the health and safety of individuals managing diabetes with technology. If a medical device malfunction has contributed to serious health problems, including hospitalizations or long-term complications, those individuals may have legal rights under state law to seek compensation.
Medical device cases can involve complex issues at the intersection of product safety, regulatory oversight, and individual harm. Working with attorneys who understand both the science of medical monitoring devices and the legal rights of injured patients can be crucial to navigating these claims.
Key Takeaways
- Certain Abbott FreeStyle Libre 3 and Libre 3 Plus sensors have been recalled/ corrected due to inaccurate glucose data that can jeopardize diabetes management.
- Reliable glucose monitoring is essential for safe treatment decisions.
- Patients affected by these devices should confirm whether their sensor is impacted and consult healthcare providers if concerns arise.
- Individuals who have experienced serious harm due to medical device failure may need legal guidance to protect their rights.
If you or a loved one were harmed because of a defective medical device, a personal injury attorney can help explore compensation options and ensure your story is heard.