4.2M Glucose Monitors Recalled Due to Overheating and Fire Risks

On April 3, 2023, the US Food and Drug Administration (FDA) posted a Class I recall notice for the Abbott FreeStyle Libre Readers after seven fires and one injury were connected to the glucose monitor products. A "Class I" rating on a recall is the FDA's strongest label, meaning there is a situation in which there is a "reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death." Since 2014, there have been 206 incidents related to the FreeStyle Libre Readers. However, there have been no reports of severe health consequences or death. According to Abbott, more than 4.2 million devices have been affected due to the recall. 

This recall is vital for those individuals with diabetes who use glucose monitors to track their blood sugar levels. As defined by the CDC, diabetes is a chronic health condition that affects how your body makes or uses insulin (a hormone that helps blood sugar enter cells, where it is used for energy.) Without insulin, the sugar can build up in your bloodstream, breaking down the body's fat and muscle, which can lead to other severe health issues. This is why individuals diagnosed with diabetes need a continuous glucose monitor, like those created by Abbott, to capture real-time glucose levels.

Before the recall was posted by the FDA, back in February, Abbott had initiated a voluntary medical device correction over the glucose monitor products in the United States due to the growing reports that the products' lithium-ion batteries swelled, overheated, and in some severe cases generated sparks or even caused a fire. The company also sent out letters regarding the Readers on February 13 to inform them of the issues. The glucose monitor products included in the recall include the following:

• FreeStyle Libre
• FreeStyle Libre 14-day
• FreeStyle Libre 2 Readers

As previously mentioned, the issue lies within the monitors used with the FreeStyle Libre line, more specifically, its lithium-ion batteries. The problem is also centered on the Reader and not the actual sensor the individuals wear on their arms. The batteries used in the Readers are recharged with a provided yellow USB cable that limits electric current to charge the battery safely. The use of other third-party components, such as USB cables or power adapters, that could allow much higher power can increase the risk of battery swelling and fires. 

Abbotts recall not only warns their customers of the dangers but also provides instructions to correct the customers of the potential errors in using the product. To avoid potential battery swelling, leakage, extreme overheating, and/or fire, Abbott urges customers their customers to do the following:

• Store the Reader between -4 °F and 140 °F
• DO NOT place the Reader in water or other liquids
• DO NOT expose the Reader power adapter or yellow USB cable to water or other liquids
• Avoid allowing blood, bleach control solution, dust, dirt, water, or any other substance in the test strip or USB port
• ONLY Charge the reader battery with the Abbott-supplied yellow USB cable and adapter

The company warned their customers that the failure to use the FreeStyle Libre system as instructed above, or in the guidelines on the label, could not only lead to injury via fire but also result in missing or creating a severely inaccurate glucose reading in the event of a treatment decision.

Regarding the overall recall, Abbott released a statement informing their customers that while there is a recall for the FreeStyle Libre line, none of the Readers are being physically recalled and do not need to be returned. Abbott says their customers can continue to safely use their Readers, so long as they use the Abbott-provided USB cable and power adapter. If customers who have a FreeStyle Libre monitor have any questions regarding how to use their provided USB cable and power adapters properly, Abbott has provided them with a guide on their website, as well as an FAQ page dedicated to help answer questions for those who want to learn more about testing, storing charging or using their Reader. 

Abbott customers can visit their website at www.FreeStyleBattery.com or connect with their customer service hotline at 1-855-632-8658. If customers believe they need to replace their power adapter or yellow USB cable, Abbott highly encourages they contact them by completing their Reader Replacement Check form as soon as possible for a replacement. For more information regarding this recall or if you have been injured due to a FreeStyle Libre reader, you can connect with us today.