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.
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 25GA Subretinal Injection Cannula is used in ophthalmic surgeries for injecting medications into the subretinal space. It is essential for treating various retinal conditions.
Voids in the seal of Tyvek pouches may compromise the sterility of the cannula, leading to a higher risk of infection due to potential contamination.
This recall is not part of a broader industry pattern.
Consumers should immediately stop using the affected cannulas to prevent potential infections, which could lead to serious health complications.
Serial numbers and catalog numbers are typically found on the packaging and product label.
Expect a refund or replacement to be processed within 4-6 weeks after following the recall instructions.
Keep records of your purchase, any correspondence with the manufacturer, and follow-up documentation regarding the recall.
The recalled product is the 25GA Subretinal Injection Cannula, catalog number VS0220.25. The recall includes lots identified through the manufacturer's notification letter.
Not sure what to do next? Our guide walks you through the process step by step.
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