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Infant child reduced energy defibrillation electrode

Official notice

28 Jan 2026

MediumHealth Canada

An official Health Canada notice concerns Infant child reduced energy defibrillation electrode. On November 21, 2024 Stryker began investigating product complaints related to the gel delamination of pediatric electrodes. Published 2026-01-28.

What to do now

Contact the manufacturer if you require additional information.

Recall number

81539

Official notice

2026-01-28

The hazard

On November 21, 2024 Stryker began investigating product complaints related to the gel delamination of pediatric electrodes.

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

318931, 315639, 315303, 316007, 320529, 315858

Skus

11101-000016, 11101-000017

Other

RA RA-81539

Model Numbers

11101-000016, 11101-000017

Recall Numbers

81539

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Affected products

Product 1

Lot or serial number - 318931, Model or catalogue number - 11101-000016

Product 2

Lot or serial number - 315639, Model or catalogue number - 11101-000016

Product 3

Lot or serial number - 315303, Model or catalogue number - 11101-000016

Product 4

Lot or serial number - 316007, Model or catalogue number - 11101-000016

Product 5

Lot or serial number - 320529, Model or catalogue number - 11101-000016

Product 6

Lot or serial number - 315858, Model or catalogue number - 11101-000016

Product 7

Lot or serial number - 318931, Model or catalogue number - 11101-000017

Product 8

Lot or serial number - 315639, Model or catalogue number - 11101-000017

Product 9

Lot or serial number - 315303, Model or catalogue number - 11101-000017

Product 10

Lot or serial number - 316007, Model or catalogue number - 11101-000017

Product 11

Lot or serial number - 320529, Model or catalogue number - 11101-000017

Product 12

Lot or serial number - 315858, Model or catalogue number - 11101-000017

Risk / hazard

On November 21, 2024 Stryker began investigating product complaints related to the gel delamination of pediatric electrodes.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Physio-control.

Source & status

Source

Health Canada

Tier

beta

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

81539

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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