Vortex Surgical Recalls TID Pharos Illuminated Depressor Over Potential Safety Issues

What Happened

Vortex Surgical Inc., based in Saint Charles, Missouri, has initiated a voluntary recall of the TID Pharos Illuminated Depressor. The FDA has designated this as a Class II recall. While the specific reason for the recall was not detailed in the initial report (listed as “XXX”), a Class II classification indicates that the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote.

Which Products Are Affected

The recall involves the following medical device:

• Product Name: Vortex Surgical TID Pharos Illuminated Depressor
• Model Number: VS0801B
• Lot Number: 2403027R
• UDI Numbers: Pouch UDI 810123481309; Box UDI 810123481712
• Quantity: 14,789 units total (8,651 in the U.S.; 6,138 internationally)

In the United States, the product was distributed to 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, and VA. International distribution includes Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, and Vietnam.

What You Should Do

Healthcare facilities and distributors should immediately check their inventory for Lot 2403027R. Vortex Surgical Inc. notified affected customers via letter starting December 16, 2025. If you have the affected product, follow the instructions provided in the firm’s notification letter regarding the return or disposition of the devices.

Why This Matters

Class II recalls are significant as they address products that could potentially cause temporary health issues. Removing these specific lots from the supply chain is a precautionary measure to ensure patient safety during surgical procedures.

Source

Data provided by the FDA under Recall Number Z-1254-2026.