FDA-Device2026-02-11Class IIPACKAGING DEFECT
Vortex Surgical Oertli laser probes recalled for compromised sterile packaging
Nationwide distributionMedical devices
What this means
Vortex Surgical has recalled certain Oertli laser probes used in eye surgery because the sterile packaging (Tyvek pouches) may have small voids or gaps in the seal. A compromised seal could allow bacteria to contaminate the sterile device, potentially leading to infection during surgery.
- Check if you have any of the affected Oertli laser probe models (23G, 25G, or 27G OS4 series) with the lot numbers listed in the recall notice
- Do not use affected devices; contact Vortex Surgical or your supplier for instructions on return or replacement
- Review your inventory against the specific UDI and lot numbers provided in the official recall notice
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
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1246-2026Want us to check the next one for you?
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