Abbott Recalls Over 4 Million FreeStyle Libre Glucose Monitoring Systems Due to Fire Risk

Intelligent Finance APP learned on Thursday that the U.S. Food and Drug Administration (FDA) classified Abbott (ABT.US)’s recently announced recall of the FreeStyle Libre glucose monitoring system as a Class I recall, the most serious type of recall. The FDA stated that Abbott began recalling more than 4 million units sold between November 2017 and February 2023 due to the risk of overheating and fire in the system’s reading device.

Abbott has reported 206 incidents related to the issue, including seven fires and one injury. No deaths have been reported.

In March this year, Abbott announced that the FDA had approved its continuous glucose monitoring systems (CGM) FreeStyle Libre 2 and FreeStyle Libre 3 for integration into automated insulin delivery (AID).

Abbott competes with Dexcom (DXCM.US), Medtronic (MDT.US), Roche (RHHBY.US), and Senseonics (SENS.US) in the CGM market. According to Allied Market Research, the CGM market size is expected to reach $32 billion by 2031.