RecalledThisWeek Search
High risk Medical DevicesClass II

Vortex Surgical 25GA Convenience Kit Recall

Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644

Updated December 16, 2025

Vortex Surgical 25GA Convenience Kits may have voids in the Tyvek pouch seals, compromising the sterile barrier and risking bacterial contamination. This could lead to serious infection if the kits are used for surgical procedures.

Is the Vortex Surgical Inc. recalled? Yes. This product was recalled by FDA on December 16, 2025. Details below.

What is recalled

Vortex Surgical 25GA Convenience Kits, catalog numbers VS0644.25-FNX, VS0644.25-FXX, and VS0644.25-XES. Affected lot numbers are those associated with identified catalog numbers.

Am I affected

You're affected if you have a Vortex Surgical 25GA Convenience Kit with catalog number VS0644.25-FNX, VS0644.25-FXX, or VS0644.25-XES. Check the package label for the catalog number.

What to do right now

Stop using these kits immediately. Contact Vortex Surgical Inc. or your medical facility's supply chain manager for instructions on return or replacement of affected kits.

The hazard

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.

Brands affected

Vortex Surgical Inc.
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1249-2026
Classification
Class II
Recalled
December 16, 2025
Read the official notice

Get free recall alerts

New Medical Devices recalls, the moment they post.

Free forever. Unsubscribe anytime. We never sell your data.

More Medical Devices recalls