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Stryker - safety alert

Official notice

20 Nov 2024

HighFDA

An official FDA notice concerns Stryker. The notice reports a fire or burn risk. Stop using the product and follow the official notice. Published 2024-11-20. Lots: 53863666, 64262566. Recall numbers: Z-0365-2025. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

1,120,860

Recall number

Z-0365-2025

Official notice

2024-11-20

The hazard

Fire or burn risk

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

53863666, 64262566

Other

UDI-DI 07613327117202

Event Ids

95502

Recall Numbers

Z-0365-2025

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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

AU · Australia

Affected area 3

CA · Canada

Affected area 4

JP · Japan

Company & contacts

Brand

Manufacturer

Not provided

Phone

Not provided

Brand: Stryker. Contact: Stryker Corporation.

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

high

Recall details

Recall number

Z-0365-2025

Event id

95502

Units affected

1,120,860

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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