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Heartsine - safety alert

Official notice

19 Jul 2023

MediumFDA

An official FDA notice concerns Heartsine. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-07-19. Recall numbers: Z-2143-2023. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

30,022

Recall number

Z-2143-2023

Official notice

2023-07-19

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

92346

Recall Numbers

Z-2143-2023

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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

AU · Australia

Affected area 3

CA · Canada

Affected area 4

DK · Denmark

Affected area 5

ES · Spain

Affected area 6

FR · France

Affected area 7

GB · United Kingdom

Affected area 8

IE · Ireland

Affected area 9

IL · Israel

Affected area 10

IS · Iceland

Affected area 11

IT · Italy

Affected area 12

JP · Japan

Affected area 13

KR · South Korea

Affected area 14

NL · Netherlands

Affected area 15

NZ · New Zealand

Affected area 16

PE · Peru

Affected area 17

PL · Poland

Affected area 18

SG · Singapore

Affected area 19

TH · Thailand

Affected area 20

ZA · South Africa

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Heartsine. Contact: HeartSine Technologies Ltd.

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-2143-2023

Event id

92346

Units affected

30,022

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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