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B Braun Medical - safety alert

Official notice

26 Mar 2025

MediumFDA

An official FDA notice concerns B Braun Medical. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2025-03-26. Recall numbers: Z-1397-2025. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

28,200

Recall number

Z-1397-2025

Official notice

2025-03-26

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.

Other

UDI-DI 04046964014017

Event Ids

96293

Recall Numbers

Z-1397-2025

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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 · CA

Location 2

US · United States · FL

Location 3

US · United States · GA

Location 4

US · United States · IL

Location 5

US · United States · IN

Location 6

US · United States · MD

Location 7

US · United States · MN

Location 8

US · United States · MO

Location 9

US · United States · NC

Location 10

US · United States · NM

Location 11

US · United States · NY

Location 12

US · United States · PA

Location 13

US · United States · TN

Location 14

US · United States · TX

Location 15

US · United States · VA

Location 16

US · United States · WA

Affected area 1

US · United States

Affected area 2

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: B Braun Medical. Contact: B Braun Medical Inc.

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-1397-2025

Event id

96293

Units affected

28,200

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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