Dallas, TX — A global personal care giant sold millions of faulty surgical gowns to U.S. hospitals and international buyers while knowingly bypassing FDA safeguards — and now Kimberly-Clark will shell out up to $40.4 million to settle criminal charges tied to the scheme.
The company admitted it sold $49 million worth of its MicroCool surgical gowns between late 2013 and late 2014, falsely marketing them as offering the highest level of protection against fluids and viruses, despite rigged testing that skirted federal premarket requirements. A former Kimberly-Clark employee faked results to dodge an FDA submission after design changes to the gowns, according to court documents.
The gowns were labeled as AAMI Level 4 — the most stringent standard for surgical apparel used in high-risk procedures — but failed to meet critical safety benchmarks, especially in fluid-resistant zones. The company did not notify the FDA of the changes, instead relying on doctored test samples to pass regulatory hurdles and keep the products on the market.
Federal prosecutors said the misconduct endangered both patients and healthcare workers. The U.S. Department of Justice called the case a serious breach of public trust, citing the company’s decision to defraud the FDA and the healthcare system for profit.
Under a deferred prosecution agreement filed in the Northern District of Texas, Kimberly-Clark will pay a $24.5 million criminal fine, forfeit $3.9 million in profits, and allocate up to $12 million for victim compensation. The agreement also requires the company to upgrade its compliance program, submit ongoing reports to the government, and fully cooperate in any further investigations.
The resolution follows a multi-year probe into the company’s sale of adulterated medical devices under the Federal Food, Drug, and Cosmetic Act. Kimberly-Clark acknowledged that it knowingly misled regulators and customers by submitting non-compliant test data and continuing to market the gowns as safe for use in infectious disease environments.
The ANSI/AAMI PB70 standard, revised in 2012, outlines strict testing for blood-borne pathogen resistance. Kimberly-Clark failed to meet those criteria in key parts of the MicroCool gown design but continued to advertise the products as compliant.
While the company did not initially self-report the violations, it later cooperated fully, including handing over internal findings, documentation, and responding to all government requests.