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Merit Medical Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C - safety alert

Official notice

23 Oct 2024

CriticalFDA

An official FDA notice concerns Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C. The notice reports an infection risk. Stop using the product and follow the official notice. Published 2024-10-23. Recall numbers: Z-0064-2025. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

14,120

Recall number

Z-0064-2025

Official notice

2024-10-23

The hazard

Infection risk

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

95343

Recall Numbers

Z-0064-2025

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Affected products

Product 1

Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C

Units affected

14,120

Risk / hazard

Infection risk

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

FR · France

Affected area 4

IE · Ireland

Affected area 5

IN · India

Affected area 6

IT · Italy

Affected area 7

JP · Japan

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

critical

Recall details

Recall number

Z-0064-2025

Event id

95343

Units affected

14,120

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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