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Dr. Joel Kaplan Inc., a manufacturer and distributor of sexual health enhancement medical devices including the MegaVac Pump System and other products, violated FDA regulations by making unapproved and misbranded device claims. The company's product labeling and website made therapeutic claims such as stating the products would "increase in length and thickness," correct penile curvature, and expand blood vessels to improve erectile function—claims that classify these products as medical devices requiring FDA approval but which the company had not obtained. The FDA inspection conducted June 27-30, 2023, identified these violations, and despite the company's multiple responses between July and November 2023, the violations remained unresolved.