Vortex Surgical Recalls Volk Single Use Vitrectomy Lenses Due to Potential Sterility Breach

What Happened

Vortex Surgical Inc. has initiated a voluntary recall of specific lots of Volk Single Use Vitrectomy Lenses. The recall was issued after it was discovered that voids may be present in the seals of the Tyvek pouches used to package the devices. A compromised sterile barrier creates a potential for bioburden contamination, which could lead to patient infection during surgical procedures.

Which Products Are Affected

The recall affects a total of 14,789 units (8,651 in the United States and 6,138 internationally). The following products are included:

1. Flat Vitrectomy Lens (Catalog VFD)

   • Pouch UDI: 810123482290
   • Box UDI: 810123482306
   • Lots: 2410036, 2411020

2. Volk Magnifying Lens (Catalog VMD)

   • Pouch UDI: 810123482825
   • Box UDI: 810123482832
   • Lot: 2411019

Distribution in the United States includes the following states: 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 providers and facilities should immediately check their inventory for the affected catalog numbers and lot numbers. Affected products should be quarantined to prevent use. Vortex Surgical Inc. notified customers of the issue via letter on December 16, 2025. For questions regarding returns or further instructions, contact Vortex Surgical Inc. at 4 Research Park Dr Ste 124, Saint Charles, MO 63304-5639.

Why This Matters

This recall is significant because the use of a medical device with a compromised sterile barrier during surgery can introduce contaminants into a sterile field, potentially leading to serious post-operative infections.

Source

FDA Recall Z-1244-2026