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Abiomed - safety alert

Official notice

1 Oct 2025

CriticalFDA

An official FDA notice concerns Abiomed. The notice reports a chemical exposure risk. Stop using the product and follow the official notice. Published 2025-10-01. Recall numbers: Z-2568-2025. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

71

Recall number

Z-2568-2025

Official notice

2025-10-01

The hazard

Chemical exposure 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

97440

Recall Numbers

Z-2568-2025

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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 · AR

Location 2

US · United States · AZ

Location 3

US · United States · CA

Location 4

US · United States · CO

Location 5

US · United States · CT

Location 6

US · United States · FL

Location 7

US · United States · GA

Location 8

US · United States · ID

Location 9

US · United States · MA

Location 10

US · United States · MI

Location 11

US · United States · MO

Location 12

US · United States · MS

Location 13

US · United States · NJ

Location 14

US · United States · NY

Location 15

US · United States · OH

Location 16

US · United States · PA

Location 17

US · United States · TX

Affected area 1

US · United States

Affected area 2

CA · Canada

Affected area 3

DE · Germany

Affected area 4

IT · Italy

Affected area 5

NL · Netherlands

Affected area 6

NO · Norway

Company & contacts

Brand

Manufacturer

Not provided

Phone

Not provided

Brand: Abiomed. Contact: Abiomed, Inc..

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class I

App estimate

critical

Recall details

Recall number

Z-2568-2025

Event id

97440

Units affected

71

Status

active

Classification

Class I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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