FDA-Device2026-01-07Class IIPROCESSING DEFECT
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe recalled for fit issues with cannula
OTHERNationwide distribution
Stop using Vortex Surgical laser probe (lot 2509040)
Some units of the Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe (catalog VS0135.25, lot 2509040) may not fit smoothly through a 25-gauge cannula as intended. This could affect proper use during medical procedures. The recall affects 221 units distributed in the US and Japan.
- If you have this device (lot 2509040), stop using it immediately
- Contact Vortex Surgical Inc. for instructions on return or replacement
- Verify your lot number matches 2509040 on the device packaging
Hazard
Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
Sold states
US and Japan
Affected count
221 units
Manufactured in
4 Research Park Dr Ste 124, N/A, Saint Charles, MO, United States
Products
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1004-2026Don't want to check this manually?
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