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HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2

Official notice

16 Sept 2026

Last checked

22 Sept 2026

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 2026-09-16. Recall numbers: Z-3120-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

11,912

Recall number

Z-3120-2026

Official notice

2026-09-16

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 0506016712067, UDI-DI 0506016712207, UDI-DI 0506016712804, UDI-DI 0506016712069

Event Ids

99568

Recall Numbers

Z-3120-2026

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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

AU · Australia

Affected area 4

BR · Brazil

Affected area 5

CA · Canada

Affected area 6

CL · Chile

Affected area 7

CO · Colombia

Affected area 8

GB · United Kingdom

Affected area 9

HK · Hong Kong

Affected area 10

IL · Israel

Affected area 11

JP · Japan

Affected area 12

KR · South Korea

Affected area 13

MY · Malaysia

Affected area 14

NL · Netherlands

Affected area 15

PL · Poland

Affected area 16

SG · Singapore

Affected area 17

TH · Thailand

Affected area 18

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-3120-2026

Event id

99568

Units affected

11,912

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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