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Integra Lifesciences - safety alert

Official notice

6 Nov 2024

MediumFDA

An official FDA notice concerns Integra Lifesciences. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2024-11-06. Lots: UDI. Recall numbers: Z-0235-2025. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

1,791

Recall number

Z-0235-2025

Official notice

2024-11-06

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.

Lots

UDI

Event Ids

95432

Recall Numbers

Z-0235-2025

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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

BR · Brazil

Affected area 9

CA · Canada

Affected area 10

CH · Switzerland

Affected area 11

CL · Chile

Affected area 12

CN · China

Affected area 13

CO · Colombia

Affected area 14

CR · Costa Rica

Affected area 15

CY · Cyprus

Affected area 16

CZ · Czech Republic

Affected area 17

DE · Germany

Affected area 18

DO · Dominican Republic

Affected area 19

ES · Spain

Affected area 20

FR · France

Affected area 21

GB · United Kingdom

Affected area 22

GR · Greece

Affected area 23

HK · Hong Kong

Affected area 24

HU · Hungary

Affected area 25

IE · Ireland

Affected area 26

IL · Israel

Affected area 27

IS · Iceland

Affected area 28

IT · Italy

Affected area 29

JO · Jordan

Affected area 30

JP · Japan

Affected area 31

KR · South Korea

Affected area 32

KW · Kuwait

Affected area 33

LT · Lithuania

Affected area 34

LU · Luxembourg

Affected area 35

MT · Malta

Affected area 36

MX · Mexico

Affected area 37

MY · Malaysia

Affected area 38

NL · Netherlands

Affected area 39

NZ · New Zealand

Affected area 40

PE · Peru

Affected area 41

PK · Pakistan

Affected area 42

PL · Poland

Affected area 43

PT · Portugal

Affected area 44

RO · Romania

Affected area 45

RS · Serbia

Affected area 46

SA · Saudi Arabia

Affected area 47

SE · Sweden

Affected area 48

SG · Singapore

Affected area 49

SI · Slovenia

Affected area 50

SV · El Salvador

Affected area 51

TR · Turkey

Affected area 52

TW · Taiwan

Affected area 53

ZA · South Africa

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Integra Lifesciences. Contact: Integra LifeSciences Corp..

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-0235-2025

Event id

95432

Units affected

1,791

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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