The U.S. Food and Drug Administration has classified a corrective action involving insulin pumps from Tandem Diabetes Care Inc. (NASDAQ:TNDM) as a Class I recall, the agency's most serious designation, citing risks of serious injury or death if the issue is not addressed.

The recall does not involve removing products from the market. Instead, it focuses on correcting affected devices currently in use.

Device Overview

Tandem's insulin pumps are battery-operated devices designed to deliver both basal and bolus insulin through a motor-driven system, using a cartridge and infusion set to administer insulin subcutaneously.

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Affected Devices And Required Action

The FDA said Tandem issued an urgent medical device correction for its Mobi insulin pumps running ...