Vortex Surgical Inc. recalls Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe

Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.

Vortex Surgical Inc. issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 11/19/2025 via email. The notice explained the issue, risk to health, and requested the use of the product be discontinued. The firm requested the response to be emailed to: ARitts@VortexSurgical.com for replacement or refund. Customer Service will provide a return label for any unused products.

• FDA enforcement recordOfficial FDA database entry for Z-1004-2026
• FDA 510(k) clearance · K220263The device's official FDA premarket clearance record
• FDA device classification · HQBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 886.4690The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Vortex Surgical Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.