12:27 PM EDT, 08/29/2025 (MT Newswires) -- (Updates with Kimberly-Clark ( KMB ) response in the last paragraph.)

Kimberly-Clark ( KMB ) has agreed to pay up to $40.4 million to resolve a criminal charge related to the sale of adulterated MicroCool surgical gowns, the Justice Department's Office of Public Affairs, or OPA, said Thursday.

The company was charged with distributing these gowns in US markets after altering them without properly notifying the Food and Drug Administration, as required by law, the OPA said.

The OPA said Kimberly-Clark ( KMB ) has admitted that "with an intent to defraud and mislead," one of its employees prepared fake test samples to avoid filing a 510(k) premarket notification with the FDA for its MicroCool surgical gowns.

The company also admitted that between late 2013 and late 2014, it sold millions of these gowns labeled as AAMI Level 4 without proper FDA clearance. In total, about $49 million worth of these faulty gowns were sold in the US and internationally, the OPA added.

Under a deferred prosecution agreement, the company will pay a $24.5 million penalty, give up $3.9 million in profits, and provide up to $12 million in victim compensation, according to the statement.

"Kimberly-Clark ( KMB ) takes its legal and compliance obligations seriously, and we are pleased to have resolved this matter involving a former healthcare business unit that was divested in 2014," the company told MT Newswires via email late Thursday.

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