FDA WARNING_LETTER - Unetixs Vascular, Inc. - December 04, 2025

Unetixs Vascular, Inc. received an FDA Warning Letter following an inspection of its Rhode Island facility conducted between September 19 and December 4, 2025. The agency determined that the company is marketing modified versions of its ROODRA and 2CP vascular diagnostic ultrasound systems without the necessary regulatory approval or clearance. The FDA found that Unetixs implemented significant design, material, and labeling changes, switching from luer to bayonet connections to prevent device misconnections. While these changes were intended to address a critical safety risk—specifically a patient death caused by an air embolism—the modifications significantly affect the devices" safety and effectiveness. Under the Federal Food, Drug, and Cosmetic Act, such substantial changes require a new premarket submission, which the company failed to provide, rendering the products adulterated and misbranded. Additionally, the letter highlights that Unetixs has not fully resolved quality system violations first identified in a 2020 Warning Letter. The FDA noted that while some progress has been made, any future corrective actions must now comply with the updated Quality Management System Regulation (QMSR), which became effective in February 2026. Unetixs Vascular must respond within 15 business days with a detailed plan and timeline for correcting these violations and preventing their recurrence. Failure to take prompt action could lead to legal consequences, including product seizures, injunctions, or financial penalties.