The FDA has escalated the Freestyle Libre System 3 recall to Class I, which is the highest level of urgency. The first recall announcement was made in November 2025 by the company, which was followed by the FDA’s public announcement on December 2. Since last month, more than 850 serious injuries and 7 deaths have been reported because of sensor issues.
As per the FDA announcement, Abbott Libre System 3 and 3 Plus sensors are providing wrong glucose readings. The device may show lower glucose readings than the accurate blood sugar level, leading to fatal harm to users.
What Led to the First Libre System 3 Recall?
Abbott claimed that the company was able to track issues with some production lines, followed by finding the cause and resolving it. According to the company’s reports, the issues came to light after some devices began reporting inaccurate data, showing much lower blood sugar levels than the actual levels.
People who use Libre Systems were faced with a threat. As wrong reports forced them into decreasing the insulin shots or eat more carbs. This can lead to severe hyperglycemia.
How Does The Device Work?
Freestyle Libre System 3 and 3 Plus are continuous glucose monitoring (CGM) devices with an in-built alarm to signal any diabetes related risks. This device can be used by anyone above the age of four. It also tracks patterns and trends, helping in predicting episodes of hyperglycemia and hypoglycemia.
This system also communicates with the connected devices for better analysis and reports.
How to Check Your Freestyle Libre 3 Sensor?
If you also have Libre 3 sensors, just rush to Abbott’s website and check if your device is also listed for recall based on the model number. FDA’s recall will affect specific model numbers of Libre System 3 and 3 Plus devices. You can check your sensor’s serial number on
- Sensor’s packaging
- Dedicated reader number OR
- Freestyle Libre app
If your sensor is included in the recall, stop using it immediately and go for a proper diabetes checkup. Replace this with medical glucose devices for a few weeks, to confirm your well-being. However, the company’s other devices are working fine, and no errors have been detected yet.
No Comments