Vortex Surgical recalled 14,789 I2 Injection Kits on December 16, 2025. Voids in the seal of Tyvek pouches may compromise sterility, posing an infection risk. Healthcare providers and patients must stop using this device 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 I2 Injection Kit is used in medical settings for injections and procedures requiring sterile conditions. Healthcare providers purchase this product to ensure safe and effective medical treatments.
Voids in the seal of the Tyvek pouches can compromise the sterile barrier, allowing contaminants to enter. This can lead to an increased risk of infections for patients.
This recall is not part of a broader industry pattern.
Consumers and healthcare providers must act swiftly to prevent potential infections. The recall may cause disruptions in medical procedures that rely on this product.
The Pouch UDI and Box UDI can be found printed on the product packaging or the accompanying documentation.
Expect a refund or replacement to be processed within 4-6 weeks after following the recall instructions.
Keep records of your purchase, including receipts and any correspondence with the manufacturer regarding the recall.
The recalled product is the Vortex Surgical I2 Injection Kit, model VS0500. The affected lot includes Pouch UDI 810123480920 and Box UDI 810123481330, Lot 2411012. It was distributed worldwide, including across the U.S. to 21 states.
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