US Sues Nevada Medical Device Maker Over Alleged Safety and Regulatory Violations

August 7, 2026
By Mintesinot Nigussie

The United States has filed a lawsuit seeking to permanently block a Nevada-based medical device manufacturer from producing and selling dental products that regulators allege violate federal safety and regulatory requirements. The civil complaint, filed on August 6 in the US District Court for the District of Nevada, alleges that Steiner Biotechnology LLC and its owners, Gregory S. Steiner and Roslynn L. Steiner, failed to comply with federal manufacturing standards and sold dental products that were adulterated or misbranded under the Federal Food, Drug, and Cosmetic Act (FDCA).

The US Department of Justice said the company’s products include synthetic bone grafting materials and dental cement used in dental procedures. Some of the devices were allegedly distributed without required premarket approvals, cleared notifications or valid investigational device exemptions. “Today’s action reflects the Department of Justice’s ongoing commitment to safeguarding patients and maintaining accountability within the medical device industry,” said Brett A. Shumate, assistant attorney general of the Justice Department’s Civil Division.

The lawsuit follows multiple inspections by the US Food and Drug Administration (FDA) between 2018 and 2025, during which investigators identified repeated violations of current good manufacturing practice (CGMP) and Quality System (QS) requirements. The FDA alleged that Steiner Biotechnology failed to maintain adequate procedures for device design controls, risk analysis, process validation, environmental controls, product quality investigations and corrective actions.

The agency said it had repeatedly warned the company over the past seven years that it was distributing Class III medical devices without required regulatory approvals. Despite warnings and commitments by the company to address the issues, regulators allege that the violations continued. “Patients deserve confidence that the medical devices they rely on are safe and effective,” said Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health. “The FDA is committed to holding manufacturers accountable when they fail to meet federal requirements.”

The government’s complaint seeks a permanent injunction requiring Steiner Biotechnology to implement sanitation and manufacturing improvements and comply with federal medical device regulations before producing or distributing additional dental products. The company’s dental products are sold across the United States, according to the complaint. The case is being handled by the Justice Department’s Civil Division, with support from the US Attorney’s Office for the District of Nevada and the FDA’s Office of the Chief Counsel.

Source: FSX Business News