FDA-Device2026-02-11Class IIPACKAGING DEFECT
Vortex Surgical 25GA Subretinal Injection Cannula recalled for compromised sterile packaging
OTHERNationwide distribution
Do not use Vortex Surgical injection cannula
Vortex Surgical Inc. is recalling certain 25GA Subretinal Injection Cannula (model VS0220.25, Lot 2410043) because the sterile Tyvek pouches may have small voids or gaps in the seal. If a pouch is compromised, the cannula inside is no longer sterile and could become contaminated with bacteria, risking infection during eye surgery.
- Check if you have Lot 2410043 (printed on packaging)
- Do not use affected cannulas for any procedures
- Contact Vortex Surgical Inc. or your surgical supplier for replacement or instructions
- If a compromised cannula was already used in a procedure, inform the patient's doctor immediately
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
25GA Subretinal Injection Cannula VS0220.25
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1248-2026Don't want to check this manually?
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