Vortex Surgical recalled 221 units of the 25ga Illuminated Flex-Tip Laser Probe on November 19, 2025. The product does not pass through a 25ga cannula smoothly, which poses a high hazard risk. Patients and healthcare providers must stop using the device immediately and follow recall instructions.
Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Vortex Surgical Inc. or your healthcare provider for instructions. Notification method: E-Mail
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The recalled product is the Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25. It has been distributed in the US and Japan and falls under Class II classification.
The recall stems from an issue where some probes do not pass through a 25ga cannula smoothly. This could lead to complications during surgical procedures.
There are no specific incidents or injuries reported in relation to this recall. However, the high hazard classification indicates potential serious risks.
Stop using the device immediately. Patients and healthcare providers should follow the manufacturer’s recall instructions and contact Vortex Surgical for further guidance.
For more information, contact Vortex Surgical Inc. via email. Visit the FDA recall page for additional details.
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