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Merit Medical - safety alert

Official notice

23 Oct 2024

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 2024-10-23. Lots: H2298616, H2298077, H2304639. Recall numbers: Z-0057-2025. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

110,650

Recall number

Z-0057-2025

Official notice

2024-10-23

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

H2298616, H2298077, H2304639

Other

UDI-DI 00884450298022, UDI-DI 00884450047248

Event Ids

95330

Recall Numbers

Z-0057-2025

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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

BE · Belgium

Affected area 4

CA · Canada

Affected area 5

FR · France

Affected area 6

GB · United Kingdom

Affected area 7

JP · Japan

Affected area 8

NL · Netherlands

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-0057-2025

Event id

95330

Units affected

110,650

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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