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OFFICIAL-SOURCE RECALL · AUSTRALIA

Cardioroot Woven Grafts Recall: Classification Class II Reason for the Action

Use the identifiers printed on your item to determine whether this recall may affect the product you own.

CountryAustraliaPublishedAugust 13, 2026Last updatedAugust 13, 2026Official source last checkedAugust 26, 2026 at 7:44 PM UTC

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Brand
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Product
Cardioroot Woven Grafts
Manufacturer
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Model number
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Date code
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The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.

Why this product was recalled

Classification Class II Reason for the Action Internal testing of samples from CARDIOROOT vascular grafts produced Integral Water Permeability (IWP) results outside the limit specified in the product’s Instructions for Use (IFU) (i.e. Instructions for Customers/Users Customers should remove all

Hazard

Classification Class II Reason for the Action Internal testing of samples from CARDIOROOT vascular grafts produced Integral Water Permeability (IWP) results outside the limit specified in the product’s Instructions for Use (IFU) (i.e. Instructions for Customers/Users Customers should remove all

Official recall notice

Cardioroot Woven Grafts

Agency: Therapeutic Goods Administration

Official publication date: August 13, 2026

Read the official AU_TGA_DRAC recall notice →

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