FreeStyle Libre Glucose Monitors Recalled

More than 4 million FreeStyle Libre glucose monitors have been recalled by Abbott because the lithium-ion batteries used in the system may get extremely hot, spark or catch fire, the Food and Drug Administration (FDA) announced.

The potential hazards may occur if the device is not properly stored or charged using something other than the company-provided charger and USB cable. Any damage, exposure to liquids or foreign material entering its ports may also increase risk.

The recall is considered a Class I by the FDA, the most severe type, because serious injury or death may occur. Days before the recall was announced, Abbott issued a safety warning to consumers on how to properly use and charge the monitors.

The monitors have been associated with 206 incidents, including at least seven fires and one injury. No deaths have been reported.

From November 2017 to February 2023, an estimated 4,210,785 devices were sold and are now subject to the recall. The affected products include all serial numbers of the FreeStyle Libre, Libre 14 Day, and Libre 2 glucose monitoring systems.

Advice to consumers

Abbott said that consumers don't need to return their devices. The FDA recommends you stop using the recalled readers and switch to a backup method if:

• You don’t have the USB cable and charger that came with the device.
• The reader appears damaged or cracked.
• There is visible swelling on the reader.
• The reader gets too hot to hold.
• The reader is no longer able to hold a charge.

If your device is damaged or if a replacement cable or charger is needed, call Abbott’s customer service line at 855-632-8658. You can check online to see if your reader needs to be replaced.

Courtesy Abbott

To avoid the potential for battery hazards, Abbott recommends you:

• Charge the reader battery only with the Abbott USB cable and charger.
• Avoid storing the reader in extremely cold or hot locations (less than -4 and above 140°F).
• Do not place the reader in water or other liquids, and avoid getting dust, dirt, blood, control solution, water, bleach or other substances in the test strip or USB port.
• Review the revised user guide and labeling and follow steps to perform a reader test to determine if your current device needs to be replaced.