FDA 483 - Vortex Surgical Inc. - January 08, 2026

Vortex Surgical Inc. in Saint Charles, MO, was inspected from January 6-8, 2026, and received one observation. The firm failed to adequately control nonconforming products, specifically Class II laser probes that were part of a recall, by improperly storing them without proper identification or adherence to company procedures and FDA commitments. This indicates a significant lapse in quality control for medical devices.