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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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.
Voids in the seal of Tyvek pouches may compromise the sterile barrier of the laser probes. This defect can lead to bioburden contamination, significantly increasing the risk of infection.
Stop using the affected laser probes immediately. Follow the recall instructions from Vortex Surgical. Contact your healthcare provider for next steps and further guidance.
For more information, contact Vortex Surgical Inc. at the link provided in the recall notice. Additional details can be found at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1245-2026.
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