Vortex Surgical recalls 25GA Convenience Kits with specific model numbers and lots due to potential voids in Tyvek pouch seals that could cause infection. Affected kits include FNX, FXX, and XES models with certain lot numbers.
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 specific 25GA Convenience Kits that may have voids in the Tyvek pouch seals. This could lead to bioburden contamination and infection if the sterile barrier is compromised.
The Tyvek pouches in the kits may have small holes or gaps in their seals. This could allow bacteria or other contaminants to enter the sterile environment, potentially causing infections during medical procedures.
Surgical staff and patients using the recalled Convenience Kits for procedures. Those handling the kits with specific model numbers and lots are most at risk.
Check for model numbers: FNX, FXX, or XES. Look for lot numbers 2410055, 2411028, or 2410057. The kits are sold with specific UDI (unique device identification) codes on the pouch and box.
Identify the model number (FNX, FXX, or XES) and lot number (2410055, 2411028, or 2410057) on the pouch and box.
The Tyvek pouches may have voids in their seals, which could lead to bioburden contamination and infection if the sterile barrier is compromised.
Affected kits include FNX (lot 2410055), FXX (lot 2411028), and XES (lot 2410057).
The recall does not require immediate discontinuation; however, you should check the model and lot numbers to determine if your kit is affected.
We’ve drafted a message you can send Vortex Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1249-2026 — Vortex Surgical Vortex Surgical Hello, I own a Vortex Surgical that is covered by recall Z-1249-2026 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.
