Days after medical device company Abbott issued a voluntary safety warning for its glucose monitoring devices, the FDA published a recall note April 6 stating that more than 4 million of the company's FreeStyle Libre readers may be prone to an issue with the lithium-ion battery that can cause extreme cases of overheating.
Although the FDA noted this is a Class 1 recall, none of Abbott's physical readers are actually being recalled, a spokesperson for Abbott clarified to Becker's via email.
A total of 4,210,785 devices that were distributed between 2017 and 2023 may be affected, according to the FDA. The devices and their provided accessories are prone to battery swelling, leakage and extreme overheating that can result in catching fire.
"Abbott reports 206 incidents, including at least seven fires, one injury and no deaths involving this issue," according to the April 6 recall notice.
The total number of reported incidents — 206 — have been tracked since 2014 and account for only 0.0017 percent of readers sold worldwide, the spokesperson for Abbott stated.
"No readers are being physically recalled and customers can continue to safely use their readers with the Abbott-provided USB cable and power adapter. Customers do not need to return their readers," the spokesperson stated.
In the April 3 alert published by the FDA prior to the official recall, Abbott said it has been notifying its customers of issues with its glucose devices since February. The company cautions users to only use the Abbott power adapter and USB cable for charging purposes as third-party cables and accessories may "allow much higher power, increasing the risk of fire." Additional safety guidance for users has also been published online, the company noted.
The FDA recommends customers stop using these devices immediately if they cannot maintain a charge, are too hot to hold or have visible cracks, damage or swelling.