Vortex Surgical Inc. recalls Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens
- Recalling company
- Vortex Surgical Inc.
- Product
- Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 16, 2025
- Reported
- Feb 11, 2026
- 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.
- Status
- Ongoing
- Quantity
- 14,789 (8651 US; 6138 OUS)
- Lot / codes
- 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
- Company location
- Saint Charles, MO
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1244-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1244-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.