The FDA has issued a 'most serious' warning regarding the recall of certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus glucose monitor sensors, citing potential for serious injury or death. Abbott Diabetes Care has reported hundreds of serious injuries and several deaths associated with the recalled devices, which may provide incorrect low glucose readings, leading to dangerous treatment decisions.
The Food and Drug Administration has now identified the recall of certain FreeStyle Libre glucose monitor sensors as "most serious" and is warning that using the recalled device may cause serious injury or death if you continue to use it.
As of Jan. 7, 2026, the FDA says Abbott Diabetes Care has reported 860 serious injuries, and seven deaths associated with some models of FreeStyle Libre 3 and FreeStyle Libre 3 Plus.In December, the FDA issued an alert for after certain FreeStyle Libre glucose monitor sensors are providing incorrect low glucose readings.The FDA says 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. These decisions may pose serious health risks, including potential injury or death, or other less serious complications. The FDA says Abbott Diabetes Care sent all affected customers a letter on Nov. 24, 2025.The affected models are:According to the FDA, FreeStyle Libre 3 readers and mobile apps are not impacted and no other Libre products or Abbott biowearables are impacted. The FDA says patients can determine if their current or unused sensor are affected by visiting www.freestylecheck.com and selecting "CONFIRM SENSOR SERIAL NUMBER." The serial number for the FreeStyle Libre 3 sensor or a FreeStyle Libre 3 Plus sensor can be found in the app or reader and also on the label on the bottom of the sensor applicator or carton.Patients should verify if their sensors are impacted and immediately discontinue use and dispose of the affected sensor.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 www.freestyle.abbott/us-en/support/contact-us.html
FDA Freestyle Libre Glucose Monitor Recall Diabetes
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Australian freestyle skier Laura Peel hurts knee in Winter Olympics training campAustralian freestyle skier Laura Peel has hurt her knee in a training camp ahead of the Milan Cortina Winter Olympics. It raises doubts about her competing in a fourth Games. The 36-year-old Peel is a two-time world champion and one of the favorites to win the women’s aerials.
Read more »
FDA's drug voucher program: House lawmaker raises new concernsA Democratic lawmaker is raising new concerns about a Food and Drug Administration program designed to drastically shorten the review of certain drugs. The initiative by FDA Commissioner Marty Makary promises ultra-fast reviews for drugs that align with “national priorities.
Read more »
House lawmaker raises new concerns over FDA's ultra-fast drug review programA Democratic lawmaker is raising new concerns about a Food and Drug Administration program designed to drastically shorten the review of certain drugs.
Read more »
House lawmaker raises new concerns over FDA's ultra-fast drug review programWASHINGTON (AP) — A Democratic lawmaker is raising new concerns about a Food and Drug Administration program designed to drastically shorten the review of
Read more »
Coalition Urges FDA to Halt Sale of Counterfeit Weight Loss DrugsA coalition of conservative and activist groups has urged FDA Commissioner Dr. Marty Makary to stop the sale of counterfeit and unsafe weight loss drugs, particularly those from Chinese manufacturers. The groups expressed concerns about these drugs being sold directly to consumers, bypassing prescriptions, and potentially causing harm. They also highlighted the exploitation of the FDA's 'greenlist' by Chinese manufacturers to import these drugs.
Read more »
FDA: Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors recalled after seven deaths, 860 injuriesThe Food and Drug Administration (FDA) has now identified the recall of certain FreeStyle Libre glucose monitor sensors as “most serious' and is warning that using the recalled device may cause serious injury or death if you continue to use it.
Read more »