Class IIReported 2026-02-11

Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27

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-1255-2026

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

25GA Backflush Pouch UDI 810123480470 Box UDI 810123480753 Lot 2411017; 27GA Backflush Retractable Pouch UDI 810123480517 Box UDI 810123480791 Lot 2411016

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