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 Oertli Laser Probes are used in various medical procedures, providing precision during surgeries. Healthcare providers purchase these devices for their reliability in minimally invasive surgeries.
The Tyvek pouch seals of the probes may have voids, compromising sterility. This breach can expose the device to contaminants, increasing the risk of infection during surgical procedures.
This recall is not part of a broader industry pattern.
This recall could delay medical procedures for patients relying on these devices, thus creating potential health risks.
Model and lot numbers can typically be found on the outer packaging or the device's labeling.
Expect a refund processing timeline of 4-6 weeks after returning the device.
Keep all receipts, correspondence, and photographs of the device as records.
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
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