Vortex Surgical I2 Injection Kit, VS0500
FDA Recall #Z-1252-2026 — Class II — December 16, 2025
Product Description
Vortex Surgical I2 Injection Kit, VS0500
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.
Recalling Firm
Vortex Surgical Inc. — Saint Charles, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
14,789 (8651 US; 6138 OUS)
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 Information
Pouch UDI 810123480920 Box UDI 810123481330 Lot 2411012
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated