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FDA-Device2026-02-11Class IIPACKAGING DEFECT

Vortex Surgical 25GA Convenience Kits recalled for compromised sterile barrier seals

Vortex Surgical
OTHERNationwide distribution

Stop using Vortex Surgical 25GA Convenience Kits

Vortex Surgical Inc. is recalling three models of 25GA Convenience Kits because the Tyvek pouches may have voids or defects in their seals. A compromised seal can allow bacteria to contaminate the sterile contents, potentially leading to infection if the kits are used.

  • Check if you have any 25GA Convenience Kits (models FNX, FXX, or XES) with the affected lot numbers: 2410055, 2411028, or 2410057
  • Stop using affected kits immediately
  • Contact Vortex Surgical Inc. or your supplier for instructions on return or disposal
  • Check the UDI codes on pouches and boxes against the recall notice to confirm if your kits are affected
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.

Sold states
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.
Affected count
14,789 (8651 US; 6138 OUS)
Manufactured in
4 Research Park Dr Ste 124, N/A, Saint Charles, MO, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1249-2026

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