Class IIReported 2026-02-11

Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES

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-1249-2026

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

1. 25GA Convenience Kit - FNX Pouch UDI 810123482917 Box UDI 810123482924 Lot 2410055 2. 25GA Convenience Kit - FXX Pouch UDI 810123482429 Box UDI 810123482443 Lot 2411028 3. 25GA Convenience Kit - XES Pouch UDI 810123482412 Box UDI 810123482436 Lot 2410057

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