Abbott has recalled the FreeStyle Libre Glucose Monitors due to the risk of extreme heat and fire.
The FDA has identified the recall as Class 1, the most severe type of recall.
The products that were recalled are:
- Product Name: FreeStyle Libre Flash Glucose Monitoring System
- FreeStyle Libre 14-day Flash Glucose Monitoring System
- FreeStyle Libre 2 Flash Glucose Monitoring System
Product models consist of all reader serial numbers.
The dates of distribution were from November 2017 to February 2023.
The devices were intended to provide continuous monitoring of glucose levels, which help people manage diabetes by detecting trends and tracking patterns in glucose levels.
Abbott recalled the items mentioned above due to the reader devices used to recharge lithium-ion batteries.
They may get extremely hot, spark, or catch on fire if not appropriately stored, charged, or used with its Abbott-provided USB cable and power adapter.
The people who may be affected include:
- People who monitor their glucose levels using the FreeStyle Libre, Libre 14-day, or Libre 2 Glucose Monitoring Systems
- Healthcare providers with patients who use FreeStyle Libre, Libre 14-day, or Libre 2 systems to monitor their glucose levels
The FDA recommends that you stop using the FreeStyle Glucose Monitoring Systems and switch to a backup method which consists of:
- You do not have the Abbott-provided USB cable and power adapter
- 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 (for example, does it turn off unexpectedly or immediately after charging?)
If your reader is damaged or you are in need of a replacement USB cable or power adapter, you can call Abbott’s Customer Service at 1-855-632-8658 seven days a week from 8 a.m. to 8 p.m. EST.