Vortex Surgical recalled 14,789 disposable forceps and cannula on December 16, 2025, due to potential bioburden contamination. The recall affects various models distributed worldwide, including 8,651 in the U.S. and 6,138 internationally. Users should stop using these devices immediately to prevent infection risk.
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 Disposable Forceps and Cannula are medical devices used in various surgical procedures for grasping and manipulating tissue. These devices are essential for ensuring precision during surgeries and are widely utilized in healthcare settings.
The recall is due to voids in the seal of Tyvek pouches, which can compromise the sterility of the devices. If the devices are not sterile, they may introduce pathogens into the surgical site, leading to infections.
This recall is not part of a broader industry pattern.
The potential for bioburden contamination presents a serious health risk, necessitating immediate action from users to prevent infection.
Look for serial numbers and UDI codes printed on the packaging of the forceps and cannula.
Expect a realistic timeline of 4-6 weeks for refund processing after returning the product.
Keep records of your purchase, any communications related to the recall, and photographs of the device.
The recall includes 15 models of disposable forceps and cannula, such as the 23GA ACTU8 Forceps Adaptive (VS0740.23) and the 25GA Soft Tip Cannula (VS0200.25). These products were sold worldwide, including in U.S. states like CA and NY, as well as countries such as Germany and Japan. The price range for these devices was not specified.
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