Abbott has issued a Class I recall for certain FreeStyle Libre 3 continuous glucose monitoring sensors after discovering they could provide dangerously inaccurate readings, the FDA announced. The recall — the most serious classification — affects three specific lots distributed in the United States during early May 2024.
The affected sensors could display incorrectly high glucose readings, potentially causing patients to administer excessive insulin or fail to recognize dangerously low blood sugar levels. “There is a potential risk for calculating higher insulin doses than needed or delaying recognition for low blood glucose levels (hypoglycemia) that could lead to significant adverse health effects or death,” according to safety notices issued to healthcare providers.
How serious is this problem?
The FDA classification speaks volumes. Regulatory officials have identified this as “the most serious type” of recall, warning that “this device may cause serious injury or death if you continue to use it.” For diabetics who rely on accurate glucose readings to manage their condition, the implications couldn’t be more critical.
Abbott has emphasized that only a “small subset” of FreeStyle Libre 3 sensors are affected. The company has established a verification website where patients can check whether their sensors are among those recalled and request free replacements if necessary.
Broader transition underway
This recall comes amid a larger product transition for Abbott’s glucose monitoring systems. The company has confirmed that both the FreeStyle Libre 2 and FreeStyle Libre 3 sensors will be discontinued as of September 30, 2025. They’ll be replaced by newer versions — the FreeStyle Libre 2 Plus and FreeStyle Libre 3 Plus sensors.
“Abbott has recently announced that as of September 30, 2025, the Libre 2 and Libre 3 CGM systems will be discontinued and replaced with the Libre 2+ and Libre 3+ CGM systems,” diabetes education specialists have noted in communications to patients.
Patients currently using the older versions will need to obtain new prescriptions, though Abbott has designed the newer Plus models to remain compatible with existing readers and smartphone applications, according to healthcare bulletins.
The company’s glucose monitoring systems have become increasingly popular alternatives to traditional finger-stick blood testing, allowing patients to scan sensors worn on the upper arm for continuous glucose readings. For many diabetics, these devices have transformed daily management of their condition.
What patients should do
Abbott has issued a voluntary medical device correction after internal findings revealed the potential for incorrect high glucose readings in the affected lots. The company recommends that patients visit freestyleconfirm.com to determine if their sensors are included in the recall.
For those with affected sensors, free replacements are being offered. In the meantime, patients may need to rely on traditional blood glucose monitoring methods as a backup verification system.
The timing of this recall — affecting products that will eventually be phased out anyway — raises questions about whether the newer Plus versions address the technical issues that led to this safety concern. That said, there’s no indication the discontinuation was directly related to the current recall.
For the millions of Americans living with diabetes, the reliability of glucose monitoring technology isn’t just a matter of convenience — it’s a daily lifeline.
