Medium risk Medical DevicesClass II

Vortex Surgical Inc. Recall

Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27

Updated December 16, 2025

Vortex Surgical Inc. is recalling Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27. 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

Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27

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

Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1255-2026
Classification
Class II
Recalled
December 16, 2025
Read the official notice

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