Vortex Surgical TID Pharos Illuminated Depressor, VS0801B

Recall Insight

This FDA Devices action (record #Z-1254-2026) was formally reported on February 11, 2026, with the manufacturer initiating the action on December 16, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Vortex Surgical Inc. is listed as the recalling firm, operating out of Saint Charles, MO. Federal records indicate 14,789 (8651 US; 6138 OUS) units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: XXX Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Austra…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. Because this recall is recent, remedy windows and replacement inventory are most likely still actively available from the firm or retailer. Always cross-check the recall number against the official agency page before relying on any summary.