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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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.
The recall stems from voids in the seal of Tyvek pouches, compromising the sterile barrier. This defect poses a risk of bioburden contamination, which may lead to serious infections if used.
As of now, there are no reported injuries or infections associated with the recalled products. The recall is classified as a Class II, indicating a potential risk to health.
Stop using the affected devices immediately. Follow the instructions provided in the recall notification or contact Vortex Surgical Inc. for further guidance on returning the product. Affected individuals should consult their healthcare provider.
For further assistance, contact Vortex Surgical Inc. at 1-800-XXX-XXXX or visit their website for more information.
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