Vortex Surgical recalls I2 Injection Kit VS050: Voids in Tyvek pouch seals may cause infection. Affected units have specific catalog numbers and lots. Stop using immediately to prevent contamination.
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.
Vortex Surgical is recalling its I2 Injection Kit (VS0500) because potential voids in the Tyvek pouch seals could compromise sterility and lead to infection. This is serious because medical devices must maintain a sterile barrier to prevent infections during procedures.
The Tyvek pouches in the kit may have small holes or gaps in their seals. This breaks the sterile barrier, allowing bacteria to enter the injection solution. If used, this could cause infections in patients during medical procedures.
Healthcare professionals using the Vortex Surgical I2 Injection Kit for medical procedures are most at risk. Patients receiving injections with compromised kits could face infections.
Check for the product code VS0500 on the kit. Look for the Pouch UDI 810123480920 and Box UDI 810123481330. The lot number 2411012 is also associated with this recall.
Discard the kit if you have the affected model and lot numbers to prevent infection risks.
The recall is due to potential voids in the Tyvek pouch seals that could compromise sterility and lead to infection.
The affected model is Vortex Surgical I2 Injection Kit VS0500 with Pouch UDI 810123480920, Box UDI 810123481330, and lot 2411012.
Check the Pouch UDI (810123480920), Box UDI (810123481330), and lot number 2411012 on your kit.
We’ve drafted a message you can send Vortex Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1252-2026 — Vortex Surgical Vortex Surgical Hello, I own a Vortex Surgical that is covered by recall Z-1252-2026 from Vortex Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
