In December 2025, the U.S. Food and Drug Administration (FDA) issued an Early Alert concerning certain continuous glucose monitoring (CGM) sensors manufactured by Abbott Diabetes Care, citing a potentially serious device issue that may compromise patient safety. These devices are widely used by individuals managing diabetes throughout New York City and across the country.
According to the FDA, specific lots of FreeStyle Libre 3 and FreeStyle Libre 3 Plus glucose sensors may provide incorrect low glucose readings. These misleading readings could cause individuals to take unnecessary or delayed medical action, including improper insulin dosing or excessive carbohydrate intake.
The FDA and Abbott advised patients to immediately check whether their sensor is affected by visiting Abbott’s verification website and to stop using any impacted sensors. The alert outlined concrete steps for patients and providers: check the sensor serial number on www.freestylecheck.com, stop using any confirmed affected sensors and dispose of them safely. Abbott has stated it will provide free replacements for affected products and recommends patients rely on traditional blood glucose testing methods if readings do not align with physical symptoms.
What Is the Freestyle Libre Recall About?
According to Abbott and the FDA, specific lots of FreeStyle Libre 3 and Libre 3 Plus sensors were found to produce falsely low glucose readings due to a manufacturing defect. These devices are designed to provide real-time blood sugar data, which patients and healthcare providers use to guide treatment decisions such as insulin dosing or carbohydrate intake.
When glucose readings are inaccurate, patients may unknowingly respond in ways that place their health in jeopardy. The FDA classified this action as a serious medical device recall, noting that continued use could lead to severe injury or death.
Reported Injuries and Scope of the Recall
Federal safety data indicates that Abbott has received hundreds of adverse event reports, including incidents involving hospitalization and death, potentially linked to the affected sensors. Millions of units were distributed nationwide, including throughout New York City, where diabetes prevalence is particularly high among underserved communities.
Patients are urged to:
- Check whether their sensor is part of the affected lot numbers
- Stop using recalled sensors immediately
- Consult healthcare providers for alternative glucose monitoring options
Why Glucose Monitor Accuracy Is Critical
Extensive medical research confirms that accurate CGM data is essential for safe diabetes management. Even modest deviations in glucose readings can result in inappropriate treatment responses, especially for insulin-dependent patients.
Peer-reviewed studies have shown that inaccurate CGM readings are associated with increased risk of hypoglycemia, hyperglycemia, emergency medical intervention, and long-term complications.
Medical Device Recalls and Patient Rights
Medical devices sold in the United States must meet strict safety and manufacturing standards. When a device fails due to design or production defects, manufacturers may be held responsible for the harm caused.
In cases involving defective glucose monitors, injured patients may face:
- Emergency hospitalizations
- Severe metabolic complications
- Long-term health consequences
- Emotional distress and financial hardship
Federal law requires manufacturers to report safety concerns, but affected individuals often must take additional steps to protect their rights and pursue compensation.
What This Means for NYC Patients and Families
New York City residents often depend on advanced medical technology to manage complex health needs in fast-paced environments. When a trusted medical device fails, the consequences can be life-altering.
If a defective glucose monitor contributed to serious harm, patients may have legal options under New York product liability law. These cases often involve detailed medical evidence, regulatory records, and expert analysis — making experienced legal guidance essential.
Key Takeaways
- Certain Abbott FreeStyle Libre 3 and Libre 3 Plus sensors were recalled due to inaccurate glucose readings
- Inaccurate CGM data can directly impact treatment decisions and patient safety
- Hundreds of serious injuries and deaths have been reported in connection with the recall
- NYC patients harmed by defective medical devices may have the right to seek compensation
- Certain sensors may be affected, check this link to determine if your sensor is affected
If you or a loved one experienced serious health complications related to a defective medical device, speaking with a personal injury attorney can help you understand your legal options and next steps