Class IIReported 2026-02-11

Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD

Recalled by Vortex Surgical Inc.

Reason for Recall

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots

A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

Recall Number

Z-1244-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-12-16

Reported

2026-02-11

Distribution

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: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.

Code Info

1. Flat Vitrectomy Lens Pouch UDI 810123482290 Box UDI 810123482306 Lots 2410036 2411020 2. Volk Magnifying Lens Pouch UDI 810123482825 Box UDI 810123482832 Lot 2411019

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.