Class IIReported 2026-02-11

25GA Subretinal Injection Cannula VS0220.25

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-1248-2026

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

Pouch UDI 810123480418 Box UDI 810123480692 Lot 2410043

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