Vortex Surgical recalled 14,789 I2 Injection Kits on December 16, 2025. Voids in the seal of Tyvek pouches may compromise sterility, posing an infection risk. Healthcare providers and patients must stop using this device 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 recalled product is the Vortex Surgical I2 Injection Kit, model VS0500. The affected lot includes Pouch UDI 810123480920 and Box UDI 810123481330, Lot 2411012. It was distributed worldwide, including across the U.S. to 21 states.
Voids in the seal of Tyvek pouches can compromise the sterile barrier. This defect raises the risk of bioburden contamination, which could lead to serious infection.
No specific incidents or injuries have been reported related to this recall, but the potential for infection represents a high concern.
Stop using the Vortex Surgical I2 Injection Kit immediately. Follow the recall instructions provided by the manufacturer and contact Vortex Surgical Inc. for further information.
For more information, contact Vortex Surgical Inc. or your healthcare provider. Visit the FDA's recall page for additional instructions.
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