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
- Source
- FDA
- Category
- Medical Devices
- Recall ID
- fda-Z-1249-2026
- Classification
- Class II
- Recalled
- December 16, 2025
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