Hundreds of injuries and several deaths linked to inaccurate glucose readings, officials say
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A newly issued alert links certain FreeStyle Libre 3 and 3 Plus glucose-monitoring sensors to at least seven deaths and hundreds of serious injuries.
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The problem stems from sensors giving falsely low glucose readings which can lead to dangerous treatment decisions like skipping insulin or overconsuming carbs.
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If you use these monitors, you should check the sensor serial number now and stop using it entirely if its part of the affected batch.
The U.S. Food and Drug Administration (FDA), together with manufacturer Abbott Diabetes Care, have sounded the alarm over certain FreeStyle Libre 3 and Libre 3 Plus sensors.
According to the FDA, certain sensors from these continuous glucose monitor (CGM) models have been shown to deliver incorrect low glucose readings.
If undetected, incorrect low glucose readings over an extended period may lead to wrong treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses, the FDA explained. These decisions may pose serious health risks, including potential injury or death, or other less serious complications.
As of mid-November 2025, Abbott has reported 736 serious injuries globally, and seven deaths possibly linked to these sensor problems. The FDA has classified the issue as a potentially high-risk one.
What consumers should do next
To fix the situation, Abbott sent letters to all customers on November 24, 2025, asking anyone using or storing the suspect sensors to immediately discontinue use and throw them away. The company is also offering free replacements for affected units.
Users are urged to check their sensor serial numbers www.freestylecheck.com and select Confirm Sensor Serial Number. The FDA has also shared some of the specifics of the affected products, which include:
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FreeStyle Libre 3 Sensor
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Model Numbers: 72081-01, 72080-01
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Unique Device Identifiers (UDI-DI): 00357599818005, 00357599819002
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FreeStyle Libre 3 Plus Sensor
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Model Numbers: 78768-01, 78769-01
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Unique Device Identifiers (UDI-DI): 00357599844011, 00357599843014
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Importantly, if you use a FreeStyle Libre 3 system: the problem affects only the sensor units. The reader and app are not impacted.
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Abbott Diabetes Care at 1-833-815-4273 or https://www.freestyle.abbott/us-en/support/contact-us.html
Posted: 2025-12-03 18:34:34















