FDA announces FreeStyle Libre continuous glucose monitor sensor recall


Abbott Diabetes Care has recalled some of its FreeStyle Libre 3 and FreeStyle Libre 3 Plus glucose sensors, the Food and Drug Administration announced on Wednesday. Photo courtesy Food and Drug Administration
Officials for Abbott Diabetes Care have recalled some of the company’s FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitor sensors for people with diabetes.
The Food and Drug Administration said Wednesday the recall applies to FreeStyle Libre 3 sensors with model numbers 72081-01 and 72080-01 and unique device identifiers 00357599818005 or 00357599819002.
Also recalled are FreeStyle Libre 3 Plus sensors with model numbers 78768-01, 78769-01 and unique device identifiers 00357599844011 or 00357599843014.
The FreeStyle Libre 3 readers and mobile apps are not subject to the recall, nor are other Libre products or Abbott bio-wearable devices.
Patients can check to see if their current and unused sensors have been recalled by visiting the FreeStyle check website, choosing the “Confirm Sensor Serial Number” link and entering the serial numbers on the devices.
The serial numbers are located on the label that appears on the bottom of the sensor applicator or its carton.
If the search confirms the device is subject to the recall, users can input their contact information to receive a free replacement.
Those who are wearing the device can find its serial number in the FreeStyle sensor app or reader.
Individuals who are using devices they have confirmed are subject to the recall immediately should remove and dispose of the device.
Healthcare providers are advised to discuss the recall with their potentially impacted patients.
Device distributors and wholesalers are advised to check their current inventories and contact their customers to retrieve recalled devices and return them via their normal return procedures.