Vortex Surgical Inc.: Device Recall
Recall #Z-1244-2026 · 12/16/2025
Recall Details
- Recall Number
- Z-1244-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Vortex Surgical Inc.
- Status
- Ongoing
- Date Initiated
- 12/16/2025
- Location
- Saint Charles, MO, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,789 (8651 US; 6138 OUS)
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.
Product Description
Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD
Distribution Pattern
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.
Other Recalls by Vortex Surgical Inc.
- Class II: Risk 12/16/2025
- Class II: Risk 12/16/2025
- Class II: Risk 12/16/2025
- Class II: Risk 12/16/2025
- Class II: Risk 12/16/2025