RecalledThisWeek Search
Medium risk Drugs & MedicationsClass II

Vortex Surgical Inc. 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 Inc. is recalling Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644. 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.

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

What is recalled

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

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

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
Drugs & Medications
Recall ID
fda-Z-1249-2026
Classification
Class II
Recalled
December 16, 2025
Read the official notice

Get free recall alerts

New Drugs & Medications recalls, the moment they post.

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

More Drugs & Medications recalls