Vortex Surgical recalled 14,789 Tecfen Retractable Membrane Polishers on December 16, 2025. The recall stems from potential voids in Tyvek pouches that may compromise sterility and lead to bioburden contamination. Healthcare providers and patients must stop using the products 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 Tecfen Retractable Membrane Polisher, model QTPR1267-23, with associated catalog numbers and lots. It was distributed worldwide, including states in the US and several countries such as Australia, France, and Germany. The total quantity recalled is 14,789 units.
Voids in the seal of Tyvek pouches could compromise the sterile barrier of the device, leading to potential bioburden contamination. This contamination poses a high risk of infection for patients.
As of the report date, no specific incidents or injuries have been documented related to this recall. However, the potential for infection due to compromised sterility necessitates immediate action.
Stop using the affected device immediately. Follow the recall instructions from Vortex Surgical Inc. and contact your healthcare provider for guidance.
To report issues or seek further information, contact Vortex Surgical Inc. directly. Visit the FDA website for more details on the recall.
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