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# Firm Pays $40 Million Over Adulterated Gowns
- URL: https://www.fdaweb.com/firm-pays-40-million-over-adulterated-gowns/
- Published: 2025-09-08T12:00:00.000Z
- Updated: 2026-09-14T15:21:10.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159824

Kimberly-Clark has agreed to pay $40 million under a deferred prosecution agreement to resolve a criminal charge that it sold adulterated MicroCool surgical gowns, according to the U.S. Department of Justice. Federal prosecutors accused the Dallas-based company of introducing the defective gowns into interstate commerce with intent to defraud and mislead. The case was investigated by the FDA’s Office of Criminal Investigations.

According to court filings in the Northern District of Texas, a Kimberly-Clark employee falsified product testing to avoid filing a new 510(k) with FDA after the company modified the gowns. The fraudulent data allowed the company to continue selling the gowns while marketing them as meeting the highest protection standard, AAMI Level 4, used in high-risk surgical procedures.

“Kimberly-Clark betrayed the trust placed in it by consumers and healthcare providers when it chose to defraud the FDA and bring adulterated surgical gowns to market for its own financial gain,” acting assistant attorney general **Matthew R. Galeotti** is quoted in a [DoJ release](https://www.justice.gov/opa/pr/kimberly-clark-corporation-pay-40m-resolve-criminal-charge-related-sale-adulterated?ref=fdaweb.com) as saying.

The gowns, sold between late 2013 and late 2014, generated roughly $49 million in sales in the U.S. and abroad. Prosecutors said millions of the company’s gowns labeled as AAMI Level 4 failed to meet required bloodborne pathogen resistance testing in critical protective zones.

Under the agreement, Kimberly-Clark will pay a $24.5 million criminal penalty, forfeit $3.9 million in profits, and set aside up to $12 million to compensate victims. The company also admitted wrongdoing and agreed to implement enhanced compliance and ethics programs, cooperate with government monitoring, and provide regular remediation reports.