Freestyle Libre Recall Issued For 4.2M Glucose Monitors After Reports of Fires, Extreme Heat

Just days after a FreeStyle Libre warning was issued about battery problems, which may cause the glucose monitors to overheat or catch on fire, a recall has been issued for over 4.2 million devices.

The U.S. Food and Drug Administration (FDA) announced the Abbott FreeStyle Libre recall on April 6, indicating that the manufacturer has become aware of at least 206 reports of the glucose monitors lithium ion battery overheating, resulting in at least seven fires and one injury.

The FreeStyle Libre system is designed to help consumers monitor their blood glucose levels in real-time and manage their diabetes using a sensor on the consumer’s arm that sends glucose readings directly to the either the handheld device or an application on the consumer’s smartphone.

Freestyle Libre Glucose Monitor Problems

The risk of problems with FreeStyle Libre glucose monitors emerged earlier this week, when the FDA issued a warning about reports where the batteries overheated, sparked and even caused fires. However, at that time, Abbott Laboratories maintained the issues with FreeStyle Libre batteries were not problematic enough to warrant a recall, since they had not been linked to any serious adverse health effects or patient injuries.

In the warning, Abbott told the FDA the problem was linked to improper charger use or by spilling liquids on the battery, causing them to experience overheating events. However, it now appears that the Freestyle Libre battery problems pose a much greater risk than the manufacturer first disclosed, as a recall has been issued for more than 4 million glucose monitors sold in recent years.

2023 Abbott FreeStyle Libre Recall

Abbott Laboratories has agreed to voluntarily recall 4,210,785 glucose management systems, including;

• FreeStyle Libre
• Libre 14 day
• Libre 2 Flash

In the recall notice, the FDA states the glucose monitors rechargeable lithium-ion batteries may become extremely hot, spark, or catch on fire if not properly stored, charged, or used with the manufacturer-provided USB cable and power adapter.

Officials indicated that any after-market USB charger may provide too much power to the batteries, leading to overheating events. Specifically, FDA officials warned the Abbott-provided USB cable and power adapter are designed to only provide a limited current to the batteries to allow them to charge safely.

“The Reader, if not properly stored, charged, or used with its Abbott provided USB cable and power adapter, may expose users to extreme heat and/or fire which can cause serious injuries or death,” officials said in the recall notice. “Additionally, users may delay or miss a critical diabetes treatment if the system cannot be used after is damaged by extreme heat.”

While only one injury has been reported in relation to the overheating and fire hazards, the FDA has classified this recall as a Class I recall, indicating the use of the product has a high probability of causing serious injury or death to consumers.

Abbott is instructing customers to stop using the FreeStyle Monitoring Systems and immediately switch to a backup device if they experience any of the following situations:

• You do not have the Abbott provided USB cable and power adapter (charger)
• The Reader appears damaged or cracked
• If there is visible swelling of the Reader
• If the Reader gets too hot to hold
• If the Reader is no longer able to hold a charge

Customers who believe their device has been damaged or compromised are being asked to contact Abbott’s customer service at 1-855-632-8658 to request a replacement.