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Integra Lifesciences - safety alert

Official notice

2 Jul 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 2025-07-02. Models: 205000DS. Recall numbers: Z-1961-2025. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

4,882

Recall number

Z-1961-2025

Official notice

2025-07-02

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

205000DS

Event Ids

96965

Model Numbers

205000DS

Recall Numbers

Z-1961-2025

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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

AU · Australia

Affected area 3

BE · Belgium

Affected area 4

BR · Brazil

Affected area 5

CA · Canada

Affected area 6

CH · Switzerland

Affected area 7

CN · China

Affected area 8

DE · Germany

Affected area 9

ES · Spain

Affected area 10

FR · France

Affected area 11

GB · United Kingdom

Affected area 12

IE · Ireland

Affected area 13

IL · Israel

Affected area 14

IT · Italy

Affected area 15

KR · South Korea

Affected area 16

NZ · New Zealand

Affected area 17

PE · Peru

Affected area 18

SE · Sweden

Affected area 19

SI · Slovenia

Affected area 20

SV · El Salvador

Affected area 21

TW · Taiwan

Affected area 22

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-1961-2025

Event id

96965

Units affected

4,882

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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