Abbott recalls certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors for incorrect low readings

On November 24, 2025, Abbott Diabetes Care sent customers a letter recommending that certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors be removed from use, because they could show glucose readings lower than actual levels.[1] Abbott announced the action the same day as a medical device correction in the United States.[5] On February 4, 2026, the FDA updated its notice to say it had classified the recall as Class I, which it calls the most serious type.[1]

What went wrong

The FDA's recall records give the reason as a manufacturing process issue that may cause carbon build-up in the sensor, leading to incorrect low glucose results.[3] Abbott said the cause was tied to one production line among several that make these sensors, and that it had found and fixed the problem.[5]

The FDA wrote that a falsely low reading that goes unnoticed over an extended period may lead to wrong treatment decisions, such as eating too many carbohydrates or skipping or delaying insulin doses.[1] Abbott said it learned of the issue through ongoing product monitoring, after users reported incorrect low readings.[3]

Which sensors are affected

The FDA notice names four sensor model numbers: 72081-01 and 72080-01 for the FreeStyle Libre 3, and 78768-01 and 78769-01 for the FreeStyle Libre 3 Plus.[1] Abbott said about 3 million U.S. sensors came from the affected line, and it estimated that about half had already expired or been used.[5]

The FDA said FreeStyle Libre 3 readers and mobile apps are not affected, and neither are FreeStyle Libre 14 day, FreeStyle Libre 2, FreeStyle Libre 2 Plus or Libre Pro sensors.[1] Abbott said it was still making Libre 3 and Libre 3 Plus sensors for replacement and new orders and did not expect significant supply disruptions.[4]

Reported injuries and deaths

On November 24, 2025, Abbott reported 736 severe adverse events worldwide (57 in the U.S.) and seven deaths, none in the U.S., potentially associated with the issue.[5] The FDA's notice says that as of January 7, 2026, Abbott had reported 860 serious injuries and seven deaths associated with it.[1]

How to check your lot number

The FDA tells people to check by sensor serial number. It says the serial number appears in the app or reader, and on the label on the bottom of the sensor applicator or carton.[1] In the FreeStyle Libre 3 app, it sits under "Last 3 Sensors" on the About screen. In the Libre app, go to Profile, then About. On the FreeStyle Libre 3 reader, open Settings, then System Status, then System Info.[1] If your sensor connects to an insulin delivery device, the FDA points you to that device's user manual.[1]

With the serial number in hand, the FDA says to visit www.FreeStyleCheck.com and select "CONFIRM SENSOR SERIAL NUMBER."[1] Abbott's site asks you to select the country where you received the sensor first.[4]

The FDA notice also links a full list of affected lots, a spreadsheet with separate tabs for products sold in and outside the U.S.[1] Its U.S. tab pairs each kit pack lot number, such as T60003054, with a part number, such as 72081-01.[2] The FDA notice does not say where the lot number is printed; the serial number check is the route it describes.

What this means for you

The FDA says patients should check whether their sensors are affected and, if one is, stop using it right away and dispose of it.[1] Abbott replaces affected sensors at no cost through FreeStyleCheck.com.[1] The FDA and Abbott say to use a blood glucose meter, or the meter built into the FreeStyle Libre 3 reader, for treatment decisions when sensor readings don't match symptoms or expectations.[1] U.S. customers with questions can call Abbott Diabetes Care at 1-833-815-4273.[1]

In openFDA data updated October 12, 2026, the recall status was still "Open, Classified."[3] For anything about your treatment or supplies, talk to your care team or pharmacist.