Vortex Surgical recalled 14,789 convenience kits on December 16, 2025, due to potential contamination risks. Voids in the seal of Tyvek pouches may compromise sterile barriers, leading to infection. Patients and healthcare providers should stop using these kits 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
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The Vortex Surgical Convenience Kits are used in medical settings for procedures requiring sterile instruments. They are purchased by healthcare providers for their convenience and efficiency in ensuring patient safety.
Voids in the seal of Tyvek pouches can compromise the sterility of medical devices, increasing the risk of infections from bioburden contamination.
This recall is not part of a broader industry pattern.
The recall could lead to significant health risks for patients if the products are used, requiring immediate action from healthcare providers.
Serial numbers and lot codes can typically be found on the packaging of the convenience kits, often near the barcode or product description.
Expect a refund or replacement to take around 4-6 weeks once the return process is initiated.
Keep records of your purchase, any communications with the manufacturer, and documentation of the recall for your records.
The recall affects three models of 25GA Convenience Kits: FNX (VS0644.25-FNX), FXX (VS0644.25-FXX), and XES (VS0644.25-XES). These products were distributed in the U.S. and internationally, with a quantity of 14,789 units recalled.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
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.
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.
Vortex Surgical recalled 14,789 units of its Lindsell Sutured IOL Marker on December 16, 2025. The recall stems from potential voids in the seal of Tyvek pouches, risking bioburden contamination. Healthcare providers and patients must stop using the device immediately.
Vortex Surgical recalled 14,789 laser probes on December 16, 2025, due to potential contamination risks. The recall affects devices distributed worldwide, including 8,651 units in the U.S. Consumers should stop using these devices immediately.
Vortex Surgical recalled 14,789 laser probes on December 16, 2025, due to potential bioburden contamination. The recall affects multiple catalog numbers distributed worldwide. Healthcare providers and patients must stop using these devices immediately.
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.
Vortex Surgical recalled 14,789 units of its 25GA Subretinal Injection Cannula on December 16, 2025, due to a compromised sterile barrier. The recall affects devices distributed worldwide, including 8,651 units in the U.S. The issue may lead to bioburden contamination and potential infection.
Vortex Surgical recalled 14,789 Disposable Diamond Dusted ILM Elevators on December 16, 2025. The recall follows concerns about voids in the seal of Tyvek pouches, which could lead to bioburden contamination. Healthcare providers and patients should stop using the devices immediately.