Abbott FreeStyle Libre 3 Recall Escalated to FDA Class 1 – Check Your Sensor Now

The FDA has escalated its recall of certain Abbott FreeStyle Libre 3 and Libre 3 Plus continuous glucose monitor (CGM) sensors to Class 1 – that’s the most serious category. This isn’t a minor software glitch. As of January 7th, Abbott has reported 860 serious injuries and seven deaths associated with the affected sensors.

If you’re using a Libre 3 or Libre 3 Plus, you need to check whether your sensor is affected. Right now.

What’s the Problem?

The affected sensors may provide glucose readings that are lower than your actual blood glucose level. That might not sound catastrophic at first, but think about it: if your CGM tells you your blood sugar is dropping when it isn’t, you might eat extra carbs or reduce your insulin dose. Do that repeatedly and you’re heading towards hyperglycaemia – potentially dangerous territory for anyone managing diabetes.

Abbott traced the issue to a single production line and says they’ve identified and resolved the cause. The problem affects around 3 million sensors, though roughly half of those had already been used or expired by the time the recall was announced in November 2025.

Which Devices Are Affected?

• FreeStyle Libre 3 Sensors: Model Numbers: 72081-01, 72080-01
• FreeStyle Libre 3 Plus Sensors: Model Numbers: 78768-01, 78769-01

Importantly, the FreeStyle Libre 3 readers and mobile apps are NOT impacted. Neither are any other Libre products – the FreeStyle Libre 14 day, FreeStyle Libre 2, FreeStyle Libre 2 Plus, Libre Pro sensors, or Abbott’s biowearables are all fine.

How to Check Your Sensor

Visit www.freestylecheck.com and select “CONFIRM SENSOR SERIAL NUMBER.” You can find your serial number in the app, on the reader, or on the label at the bottom of your sensor applicator or carton.

If your sensor is affected, Abbott says to stop using it immediately, remove and dispose of it, and switch to a traditional blood glucose meter or another CGM. The company is offering free replacement sensors.

My Take

This is serious stuff. Class 1 recalls are reserved for situations where there’s a reasonable probability that use of the product will cause serious adverse health consequences or death. Seven deaths and 860 serious injuries certainly qualifies.

The good news – if you can call it that – is that no additional deaths have been reported since November 14th 2025. Abbott also says they don’t expect significant supply disruptions for replacement sensors.

If you’re in the US and have questions or experienced problems, contact Abbott Diabetes Care at 1-833-815-4273.

For those of you using CGMs for athletic purposes rather than diabetes management, this is a reminder that these devices are not infallible, even though they are classed as medical-grade devices.

Sources: FDA, Medscape, American Hospital Association

Last Updated on 6 February 2026 by the5krunner

the5krunner

tfk is the founder and author of the5krunner, an independent endurance sports technology publication. With 20 years of hands-on testing of GPS watches and wearables, and competing in triathlons at an international age-group level, tfk provides in-depth expert analysis of fitness technology for serious athletes and endurance sport competitors.