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Vortex Surgical Inc. recalls Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
Recalled February 11, 2026 · FDA recall Z-1255-2026 · Vortex Surgical
Hazard
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. · FDA Class II
Units
14,789 (8651 US; 6138 OUS)
Sold at
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.
Description
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.
Product
Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
Manufacturer(s)
Vortex Surgical Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →