Vortex Surgical recalled 14,789 units of its 25GA I.D.D. Internal Delivery Device on December 16, 2025. The recall stems from potential voids in the seal of Tyvek pouches that may compromise sterility, leading to infection risks. Healthcare providers and patients are urged to stop using the device immediately and follow recall instructions.
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 25GA I.D.D. Internal Delivery Device, model VS0250.25. It was sold worldwide, including in the US and various foreign countries, with a total of 14,789 units recalled. The affected catalog number includes Pouch UDI 810123480456 and Box UDI 810123480739, Lot 2410044.
The recall is due to potential voids in the seal of Tyvek pouches, which can compromise the sterile barrier. This defect poses a risk of bioburden contamination, increasing the likelihood of infection.
As of the recall date, there are no reported injuries or deaths associated with the defect. However, the risk of infection remains a significant concern.
Patients and healthcare providers should immediately stop using the device. Follow the manufacturer's instructions for the recall and contact Vortex Surgical Inc. or your healthcare provider for further guidance.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1250-2026 or contact Vortex Surgical Inc. directly.
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