FDA-Device2026-02-11Class II

Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5. 25G Laser Probe OS4 Illuminated Flex-Tip VK401215 6. 25G Laser Probe OS4 Intuitive Exendable VK401325 7. 27G Laser Probe OS4 Intuitive Exendable VK401327

Vortex Surgical Inc.

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1246-2026

Original summary

Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5. 25G Laser Probe OS4 Illuminated Flex-Tip VK401215 6. 25G Laser Probe OS4 Intuitive Exendable VK401325 7. 27G Laser Probe OS4 Intuitive Exendable VK401327 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. 1. 23G Laser Probe OS4 Flex-Tip Pouch UDI 810123483716 Box UDI 810123483792 Lot 2410031 2. 23G Laser Probe OS4 Illuminated Flex-Tip Pouch UDI 810123483730 Box UDI 810123483815 Lot 2410034 3. 23G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483761 Box UDI 810123483846 Lot 2410033 4. 25G Laser Probe OS4 Flex-Tip Pouch UDI 810123483723 Box UDI 810123483808 Lot 2410032 2410058 2411022; 5. 25G Laser Probe OS4 Illuminated Flex-Tip Pouch UDI 810123483747 Box UDI 810123483822 Lot 2410035 6. 25G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483778 Box UDI 810123483853 Lot 2412025 7. 27G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483785 Box UDI 810123483860 Lot 2411021 Distribution: 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 quantity: 14,789 (8651 US; 6138 OUS)

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