FDA-Device2026-02-11Class IIPACKAGING DEFECT
Vortex Surgical 25GA and 27GA Backflush needles recalled for compromised sterile packaging
What this means
Vortex Surgical has recalled certain 25GA Backflush and 27GA Backflush Retractable surgical needles because their Tyvek sterile packaging pouches may have small voids in the seal. A damaged seal can allow bacteria to contaminate the needle, which could cause infection if used in surgery.
- Check if you have Vortex Surgical 25GA Backflush (catalog VS0270.25, Lot 2411017) or 27GA Backflush Retractable (catalog VS0275.27, Lot 2411016) needles
- Do not use these needles for any procedures
- Contact your supplier or Vortex Surgical for instructions on returning or replacing the affected products
- If a patient received surgery with one of these needles, consult with your healthcare provider about monitoring for signs of infection
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
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
Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1255-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.