Vortex Surgical recalled 14,789 surgical backflush pouches on December 16, 2025, due to compromised sterile barriers. The recall affects catalog numbers VS0270.25 and VS0275.27, with potential for bioburden contamination. Healthcare providers and patients should stop using these devices 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 Vortex Surgical backflush pouches are used in medical procedures to ensure a sterile environment during surgeries. They are essential for maintaining hygiene and preventing infections in patients.
The voids in the seal of Tyvek pouches can compromise the sterility of the contents, increasing the risk of bioburden contamination. This contamination can lead to serious infections in patients.
This recall is not part of a broader industry pattern.
The recall poses a significant safety concern, as using contaminated medical devices could lead to infections, which may require treatment and could impact patient health.
Look for the catalog number and lot information on the box or pouch itself.
Expect refund processing to take 4-6 weeks.
Keep receipts, communication records with the manufacturer, and take photographs of the product in case of disputes.
The recall involves Vortex Surgical 25GA Backflush Pouches (Catalog Number VS0270.25) and 25GA Backflush Retractable Pouches (Catalog Number VS0275.27). These products were distributed worldwide, including all U.S. states and multiple foreign countries, and were sold in quantities of 14,789, with 8,651 in the U.S. and 6,138 internationally.
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