FDA Finalizes Class I Recalls for Abbott Glucose Sensors; Lawsuit Filed

The FDA finalized four Class I recalls for Abbott's continuous glucose monitoring (CGM) sensors. This action follows safety concerns Abbott initially reported in November.

Class I is the FDA's most serious recall designation. The FDA uses this designation when a product's use may cause serious adverse health consequences or death.

A sensor user filed a lawsuit against Abbott concurrent with the recalls. The suit alleges Abbott concealed information regarding the devices' safety issues.

This news precedes Abbott's fourth-quarter 2025 earnings release. The company expects to release earnings on January 22.