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Heartsine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J - safety alert

Official notice

29 Oct 2025

MediumFDA

An official FDA notice concerns HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2025-10-29. Lots: H017-002-174, H023-002-051, H017-002-173, H023-002-050, H017-002-178 and 2 more. Recall numbers: Z-0288-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

1,291,165

Recall number

Z-0288-2026

Official notice

2025-10-29

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.

Lots

H017-002-174, H023-002-051, H017-002-173, H023-002-050, H017-002-178, H017-002-071, H023-002-009

Event Ids

97651

Recall Numbers

Z-0288-2026

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Affected products

Product 1

HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J

Units affected

1,291,165

Risk / hazard

Health risk requiring medical assessment

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

AE · United Arab Emirates

Affected area 3

AR · Argentina

Affected area 4

AT · Austria

Affected area 5

AU · Australia

Affected area 6

BE · Belgium

Affected area 7

BR · Brazil

Affected area 8

CA · Canada

Affected area 9

CH · Switzerland

Affected area 10

CL · Chile

Affected area 11

CO · Colombia

Affected area 12

CR · Costa Rica

Affected area 13

CY · Cyprus

Affected area 14

CZ · Czech Republic

Affected area 15

DE · Germany

Affected area 16

DK · Denmark

Affected area 17

EE · Estonia

Affected area 18

EG · Egypt

Affected area 19

ES · Spain

Affected area 20

FI · Finland

Affected area 21

FR · France

Affected area 22

GB · United Kingdom

Affected area 23

GR · Greece

Affected area 24

HK · Hong Kong

Affected area 25

HR · Croatia

Affected area 26

HU · Hungary

Affected area 27

IE · Ireland

Affected area 28

IL · Israel

Affected area 29

IS · Iceland

Affected area 30

IT · Italy

Affected area 31

JO · Jordan

Affected area 32

JP · Japan

Affected area 33

KR · South Korea

Affected area 34

KW · Kuwait

Affected area 35

LT · Lithuania

Affected area 36

LV · Latvia

Affected area 37

MT · Malta

Affected area 38

MX · Mexico

Affected area 39

MY · Malaysia

Affected area 40

NL · Netherlands

Affected area 41

NO · Norway

Affected area 42

NZ · New Zealand

Affected area 43

PE · Peru

Affected area 44

PL · Poland

Affected area 45

PT · Portugal

Affected area 46

RO · Romania

Affected area 47

RU · Russia

Affected area 48

SA · Saudi Arabia

Affected area 49

SE · Sweden

Affected area 50

SG · Singapore

Affected area 51

SI · Slovenia

Affected area 52

SK · Slovakia

Affected area 53

TH · Thailand

Affected area 54

TR · Turkey

Affected area 55

TW · Taiwan

Affected area 56

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-0288-2026

Event id

97651

Units affected

1,291,165

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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