25GA Subretinal Injection Cannula VS0220.25
FDA Recall #Z-1248-2026 — Class II — December 16, 2025
Product Description
25GA Subretinal Injection Cannula VS0220.25
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 810123480418 Box UDI 810123480692 Lot 2410043
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated