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Integra Lifesciences - safety alert

Official notice

12 Nov 2025

CriticalFDA

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 2025-11-12. Recall numbers: Z-0373-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

16,251

Recall number

Z-0373-2026

Official notice

2025-11-12

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.

Event Ids

97623

Recall Numbers

Z-0373-2026

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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

BR · Brazil

Affected area 8

CA · Canada

Affected area 9

CH · Switzerland

Affected area 10

CL · Chile

Affected area 11

CO · Colombia

Affected area 12

CY · Cyprus

Affected area 13

CZ · Czech Republic

Affected area 14

DE · Germany

Affected area 15

ES · Spain

Affected area 16

FR · France

Affected area 17

GB · United Kingdom

Affected area 18

GR · Greece

Affected area 19

IE · Ireland

Affected area 20

IN · India

Affected area 21

IT · Italy

Affected area 22

JO · Jordan

Affected area 23

JP · Japan

Affected area 24

KR · South Korea

Affected area 25

LT · Lithuania

Affected area 26

MX · Mexico

Affected area 27

NL · Netherlands

Affected area 28

NZ · New Zealand

Affected area 29

PT · Portugal

Affected area 30

SA · Saudi Arabia

Affected area 31

SE · Sweden

Affected area 32

SG · Singapore

Affected area 33

SI · Slovenia

Affected area 34

TH · Thailand

Affected area 35

TR · Turkey

Affected area 36

TW · Taiwan

Affected area 37

VN · Vietnam

Affected area 38

ZA · South Africa

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Integra Lifesciences. Contact: Integra LifeSciences Corp. (NeuroSciences).

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class I

App estimate

critical

Recall details

Recall number

Z-0373-2026

Event id

97623

Units affected

16,251

Status

active

Classification

Class I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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