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Heartsine - safety alert

Official notice

6 Aug 2025

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 2025-08-06. Models: 360P. Recall numbers: Z-2174-2025. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

190,516

Recall number

Z-2174-2025

Official notice

2025-08-06

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.

Skus

360P

Other

UDI-DI 0506016712067, UDI-DI 0506016712068, UDI-DI 0506016712069, UDI-DI 0506016712070, UDI-DI 05060167128042, UDI-DI 0506016712806, UDI-DI 0506016712808

Event Ids

96890

Model Numbers

360P

Recall Numbers

Z-2174-2025

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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

AR · Argentina

Affected area 3

AT · Austria

Affected area 4

AU · Australia

Affected area 5

BR · Brazil

Affected area 6

CA · Canada

Affected area 7

CL · Chile

Affected area 8

CO · Colombia

Affected area 9

CR · Costa Rica

Affected area 10

GB · United Kingdom

Affected area 11

HK · Hong Kong

Affected area 12

IE · Ireland

Affected area 13

IL · Israel

Affected area 14

JP · Japan

Affected area 15

KR · South Korea

Affected area 16

MX · Mexico

Affected area 17

MY · Malaysia

Affected area 18

NL · Netherlands

Affected area 19

NZ · New Zealand

Affected area 20

PL · Poland

Affected area 21

SG · Singapore

Affected area 22

TH · Thailand

Affected area 23

TW · Taiwan

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-2174-2025

Event id

96890

Units affected

190,516

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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