Vortex Surgical recalls 25GA I.D.D. Internal Delivery Device with potential voids in Tyvek pouch seals, risking infection. Affected units have specific catalog numbers and lots.
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 25GA I.D. Delivery Device because pouch seals might have voids, which could let bacteria in and cause infections. This is serious for medical use since sterile devices are critical during procedures.
The Tyvek pouch seals may have small holes or gaps. This breaks the sterile barrier, allowing bacteria to enter the device. If the device is used during surgery, it could cause infections in patients.
Healthcare professionals using the device for medical procedures are most at risk. Patients receiving the device could be affected if the seal is compromised.
Check for catalog number 810123480456 on the pouch UDI and lot number 2410044 on the box UDI. The device model is Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25.
Look for catalog number 810123480456 on the pouch UDI and lot number 2410044 on the box UDI.
The recall states there may be voids in the seal that could lead to infection, so it is not safe to use without checking the specific catalog and lot numbers.
Check the catalog number on the pouch UDI and lot number on the box UDI to see if it's affected. If it is, contact Vortex Surgical for instructions.
Ensure the device has the correct catalog number and lot number to avoid compromised seals. Only use devices that have been verified as safe.
We’ve drafted a message you can send Vortex Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1250-2026 — Vortex Surgical Vortex Surgical Hello, I own a Vortex Surgical that is covered by recall Z-1250-2026 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.
