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Covidien Lp Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB - safety alert

Official notice

10 Apr 2024

MediumFDA

An official FDA notice concerns Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2024-04-10. Lots: Serial. Recall numbers: Z-1465-2024. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

124,863

Recall number

Z-1465-2024

Official notice

2024-04-10

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

Serial

Event Ids

94131

Recall Numbers

Z-1465-2024

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Affected products

Product 1

Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB

Units affected

124,863

Risk / hazard

Health risk requiring medical assessment

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

AT · Austria

Affected area 4

AU · Australia

Affected area 5

BE · Belgium

Affected area 6

BG · Bulgaria

Affected area 7

BR · Brazil

Affected area 8

CA · Canada

Affected area 9

CH · Switzerland

Affected area 10

CO · Colombia

Affected area 11

CZ · Czech Republic

Affected area 12

DE · Germany

Affected area 13

DK · Denmark

Affected area 14

EE · Estonia

Affected area 15

ES · Spain

Affected area 16

FI · Finland

Affected area 17

FR · France

Affected area 18

GB · United Kingdom

Affected area 19

GR · Greece

Affected area 20

HK · Hong Kong

Affected area 21

HR · Croatia

Affected area 22

HU · Hungary

Affected area 23

IE · Ireland

Affected area 24

IL · Israel

Affected area 25

IT · Italy

Affected area 26

JO · Jordan

Affected area 27

JP · Japan

Affected area 28

KR · South Korea

Affected area 29

LU · Luxembourg

Affected area 30

MT · Malta

Affected area 31

MX · Mexico

Affected area 32

MY · Malaysia

Affected area 33

NL · Netherlands

Affected area 34

NO · Norway

Affected area 35

NZ · New Zealand

Affected area 36

PL · Poland

Affected area 37

PT · Portugal

Affected area 38

RO · Romania

Affected area 39

SA · Saudi Arabia

Affected area 40

SE · Sweden

Affected area 41

SG · Singapore

Affected area 42

SI · Slovenia

Affected area 43

SK · Slovakia

Affected area 44

TH · Thailand

Affected area 45

TR · Turkey

Affected area 46

TW · Taiwan

Affected area 47

ZA · South Africa

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Covidien Lp. Contact: Covidien, LP.

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-1465-2024

Event id

94131

Units affected

124,863

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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