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FDA-Device2026-02-11Class IIPACKAGING DEFECT

Vortex Surgical laser probes recalled for compromised sterile packaging

Vortex Surgical
OTHERNationwide distribution

Stop using Vortex Surgical laser probes

Vortex Surgical laser probes used in eye surgery may have small voids or gaps in their sterile packaging seals. If the seal is compromised, bacteria could contaminate the sterile device and cause infection during surgery. No injuries have been reported so far.

  • Do not use affected laser probes if you have them in inventory
  • Check your stock against the lot numbers and catalog numbers listed in the recall
  • Contact your Vortex Surgical distributor or the company directly for instructions on returning or replacing affected devices
  • If you have already used an affected device on a patient, consult with your infection control team
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
Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat No. VS0130.25 4. 25GA Laser Probe Illuminated Curved Cat No. VS0125.25B 5. 25GA Laser Probe MaxReach Cat No. VS0140.25 6. 25GA Laser Probe Straight Cat No. VS0110.25

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1245-2026

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