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Merit Medical - safety alert

Official notice

26 Nov 2025

MediumFDA

An official FDA notice concerns Merit Medical. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2025-11-26. Recall numbers: Z-0533-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

217,141

Recall number

Z-0533-2026

Official notice

2025-11-26

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

97446

Recall Numbers

Z-0533-2026

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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 · AK

Location 2

US · United States · AL

Location 3

US · United States · AR

Location 4

US · United States · AZ

Location 5

US · United States · CA

Location 6

US · United States · CO

Location 7

US · United States · CT

Location 8

US · United States · DC

Location 9

US · United States · DE

Location 10

US · United States · FL

Location 11

US · United States · GA

Location 12

US · United States · HI

Location 13

US · United States · IA

Location 14

US · United States · ID

Location 15

US · United States · IL

Location 16

US · United States · IN

Location 17

US · United States · KS

Location 18

US · United States · KY

Location 19

US · United States · LA

Location 20

US · United States · MA

Location 21

US · United States · MD

Location 22

US · United States · ME

Location 23

US · United States · MI

Location 24

US · United States · MN

Location 25

US · United States · MO

Location 26

US · United States · MS

Location 27

US · United States · MT

Location 28

US · United States · NC

Location 29

US · United States · ND

Location 30

US · United States · NE

Location 31

US · United States · NH

Location 32

US · United States · NJ

Location 33

US · United States · NM

Location 34

US · United States · NV

Location 35

US · United States · NY

Location 36

US · United States · OH

Location 37

US · United States · OK

Location 38

US · United States · OR

Location 39

US · United States · PA

Location 40

US · United States · RI

Location 41

US · United States · SC

Location 42

US · United States · SD

Location 43

US · United States · TN

Location 44

US · United States · TX

Location 45

US · United States · UT

Location 46

US · United States · VA

Location 47

US · United States · WA

Location 48

US · United States · WI

Location 49

US · United States · WV

Affected area 1

US · United States

Affected area 2

AE · United Arab Emirates

Affected area 3

AU · Australia

Affected area 4

BE · Belgium

Affected area 5

CA · Canada

Affected area 6

CH · Switzerland

Affected area 7

CN · China

Affected area 8

CY · Cyprus

Affected area 9

DE · Germany

Affected area 10

ES · Spain

Affected area 11

FI · Finland

Affected area 12

FR · France

Affected area 13

GB · United Kingdom

Affected area 14

IS · Iceland

Affected area 15

IT · Italy

Affected area 16

JP · Japan

Affected area 17

KR · South Korea

Affected area 18

MX · Mexico

Affected area 19

NL · Netherlands

Affected area 20

NO · Norway

Affected area 21

NZ · New Zealand

Affected area 22

PT · Portugal

Affected area 23

SA · Saudi Arabia

Affected area 24

SE · Sweden

Affected area 25

SK · Slovakia

Affected area 26

TH · Thailand

Affected area 27

TW · Taiwan

Affected area 28

ZA · South Africa

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Merit Medical. Contact: Merit Medical Systems, Inc..

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-0533-2026

Event id

97446

Units affected

217,141

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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