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Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5

Official notice

30 Sept 2026

Last checked

6 Oct 2026

MediumFDA

An official FDA notice concerns Intervascular Sas. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2026-09-30. Models: HEWROOT0024, HEWROOT0026, HEWROOT0028, HEWROOT0030, HEWROOT0032 and 1 more. Recall numbers: Z-3258-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

16,329

Recall number

Z-3258-2026

Official notice

2026-09-30

The hazard

Health risk requiring medical assessment

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Skus

HEWROOT0024, HEWROOT0026, HEWROOT0028, HEWROOT0030, HEWROOT0032, HEWROOT0034

Other

UDI-DI 00384401013884, UDI-DI 00384401013891, UDI-DI 00384401013907, UDI-DI 00384401013914, UDI-DI 00384401013921, UDI-DI 00384401013938

Event Ids

99745

Model Numbers

HEWROOT0024, HEWROOT0026, HEWROOT0028, HEWROOT0030, HEWROOT0032, HEWROOT0034

Recall Numbers

Z-3258-2026

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Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States

Affected area 1

US · United States

Affected area 2

AE · United Arab Emirates

Affected area 3

AR · Argentina

Affected area 4

AT · Austria

Affected area 5

AU · Australia

Affected area 6

BE · Belgium

Affected area 7

BG · Bulgaria

Affected area 8

CA · Canada

Affected area 9

CH · Switzerland

Affected area 10

CZ · Czech Republic

Affected area 11

DE · Germany

Affected area 12

DK · Denmark

Affected area 13

EE · Estonia

Affected area 14

ES · Spain

Affected area 15

FI · Finland

Affected area 16

FR · France

Affected area 17

GB · United Kingdom

Affected area 18

GR · Greece

Affected area 19

HK · Hong Kong

Affected area 20

HU · Hungary

Affected area 21

IE · Ireland

Affected area 22

IL · Israel

Affected area 23

IN · India

Affected area 24

IT · Italy

Affected area 25

JO · Jordan

Affected area 26

KW · Kuwait

Affected area 27

LU · Luxembourg

Affected area 28

LV · Latvia

Affected area 29

MY · Malaysia

Affected area 30

NL · Netherlands

Affected area 31

NO · Norway

Affected area 32

NZ · New Zealand

Affected area 33

PL · Poland

Affected area 34

PT · Portugal

Affected area 35

RO · Romania

Affected area 36

RS · Serbia

Affected area 37

RU · Russia

Affected area 38

SA · Saudi Arabia

Affected area 39

SE · Sweden

Affected area 40

SI · Slovenia

Affected area 41

TR · Turkey

Affected area 42

TW · Taiwan

Affected area 43

ZA · South Africa

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Intervascular Sas. Contact: INTERVASCULAR, SAS.

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-3258-2026

Event id

99745

Units affected

16,329

Status

active

Classification

Class II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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