US EditionFaulty glucose monitors linked to 7 deaths and more than 700 injuries, FDA warns
About 3 million Abbott FreeStyle Libre 3 sensors in the U.S. may give false low glucose readings, linked to 7 deaths and over 700 serious injuries worldwide, FDA warns.
- On Dec. 2, 2025 the U.S. Food and Drug Administration warned that certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors were linked to at least seven deaths and more than 700 serious injuries, urging patients to stop using and dispose of affected sensors immediately.
- Abbott said a manufacturing issue on one production line caused some sensors to show incorrect low glucose readings and initiated a medical device correction after internal testing and a Nov. 24, 2025 customer letter.
- About 3 million sensors in the U.S. are potentially affected, including FreeStyle Libre 3 Sensor model numbers 72081-01, 72080-01, and FreeStyle Libre 3 Plus Sensor model numbers 78768-01, 78769-01, with UDIs 00357599818005, 00357599819002, 00357599844011, 00357599843014.
- Consumers can verify serial numbers and request free replacements at FreeStyleCheck.com, while Abbott said it expects no major supply delays and the FDA will monitor the issue for a possible recall.
- Millions who rely on continuous glucose monitors face risks because incorrect low readings may lead users aged four and older to skip insulin or consume excess carbohydrates, Health Canada also issued a recall.
154 Articles
154 Articles
3 million diabetes glucose monitors recalled after 7 deaths and over 700 injuries
Abbott Diabetes Care has recalled certain glucose monitoring sensors after reports of seven deaths and more than 700 injuries possibly linked to malfunctioning devices that could provide inaccurate readings.
Abbott issues ‘urgent' message to patients after medical devices linked to 700 injuries, 7 deaths
The Food and Drug Administration issued an alert about a "potentially high-risk issue" regarding malfunctioning Abbott glucose sensors that have been linked to more than 700 serious injuries and 7 deaths, with patients advised to "immediately" discontinue using the products.
FDA Warning For Abbott Glucose Sensors After 700 Injuries, 7 Deaths - Abbott Laboratories (NYSE:ABT)
The U.S. Food and Drug Administration (FDA) in December issued a safety alert urging people with diabetes to stop using select glucose sensors made by Abbott Laboratories’ (NYSE:ABT) Diabetes Care, after the company linked the devices to seven deaths and hundreds of serious injuries. • Abbott Laboratories shares are consolidating. What’s ahead for ABT stock? Regulators said certain models of the company's FreeStyle Libre 3 sensors may inaccurate…
Faulty glucose monitors linked to 7 deaths and more than 700 injuries, FDA warns (Business)
The U.S. Food and Drug Administration is warning people to stop using certain types of glucose monitor sensors, which were also sold in Canada, after the company that makes them, Abbott Diabetes Care, said the devices were linked to seven deaths and more than 700 injuries. Certain FreeStyle Libre 3 ...
Coverage Details
Bias Distribution
- 79% of the sources are Center
Factuality
To view factuality data please Upgrade to Premium
