Vortex Surgical recalled 14,789 laser probes on December 16, 2025, due to potential contamination risks. The recall affects devices distributed worldwide, including 8,651 units in the U.S. Consumers should stop using these devices immediately.
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.
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: Letter
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The recall includes several models: 23G Laser Probe OS4 Flex-Tip VK401113, 23G Laser Probe OS4 Illuminated Flex-Tip VK401213, 23G Laser Probe OS4 Intuitive Extendable VK401323, 25G Laser Probe OS4 Flex-Tip VK401115, 25G Laser Probe OS4 Illuminated Flex-Tip VK401215, 25G Laser Probe OS4 Intuitive Extendable VK401325, and 27G Laser Probe OS4 Intuitive Extendable VK401327. The probes were sold worldwide, including in the U.S. states of Alabama, Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North car
The recall stems from potential voids in the seals of Tyvek pouches that could compromise the sterile barrier. A compromised barrier raises the risk of bioburden contamination, which could lead to serious infections.
As of now, no specific injuries or incidents have been reported related to this recall. However, the potential for infection poses a significant health risk.
Consumers and healthcare providers should immediately stop using the recalled devices. Follow the recall instructions provided by Vortex Surgical and contact them or your healthcare provider for further instructions.
For more information, contact Vortex Surgical Inc. at the provided website link: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1246-2026.
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