Vortex Surgical recalled 14,789 laser probes on December 16, 2025, due to potential bioburden contamination. The recall affects multiple catalog numbers distributed worldwide. Healthcare providers and patients must 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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Vortex Surgical laser probes are used in various medical procedures for precision and effectiveness. These devices are critical for healthcare providers during surgeries and other interventions.
Voids in the seal of Tyvek pouches may compromise the sterile barrier, allowing bacteria and contaminants to enter, which can lead to severe infections.
This recall is not part of a broader industry pattern.
The recall may cause inconvenience for healthcare providers and patients, requiring immediate attention to ensure safety and prevent potential infections.
The catalog numbers and lot numbers are located on the Tyvek pouches and the product packaging.
Expect a response regarding refund or replacement within 4-6 weeks after initiating the recall process.
Keep a record of the product details, any correspondence regarding the recall, and medical documents related to its use.
The recall includes the following catalog numbers: 23GA Laser Probe Curved (VS0120.23), 25GA Laser Probe Curved (VS0120.25), 25GA Laser Probe Flex-Tip (VS0130.25), 25GA Laser Probe Illuminated Curved (VS0125.25B), 25GA Laser Probe MaxReach (VS0140.25), and 25GA Laser Probe Straight (VS0110.25). These products were distributed in the U.S. and internationally to various countries.
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