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Olympus medical single use electrosurgical snare sd-400

Official notice

30 Oct 2025

MediumHealth Canada

An official Health Canada notice concerns Olympus medical single use electrosurgical snare sd-400. Olympus's investigation determined that small holes may occur during packaging of SD-400 device pouches into the shelf carton and/or during transportation of the shelf carton. Users should cease usage of the affected lots immediately due to the potential sterility breach. Published 2025-10-30.

What to do now

Contact the manufacturer if you require additional information.

Recall number

78388

Official notice

2025-10-30

The hazard

Olympus's investigation determined that small holes may occur during packaging of SD-400 device pouches into the shelf carton and/or during transportation of the shelf carton. Users should cease usage of the affected lots immediately due to the potential sterility breach.

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.

Recall Numbers

78388

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Affected products

Product 1

Affected products - Single Use Electrosurgical Snare SD-400, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - SD-400U-15

Product 2

Affected products - Single Use Electrosurgical Snare SD-400, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - SD-400U-10

Risk / hazard

Olympus's investigation determined that small holes may occur during packaging of SD-400 device pouches into the shelf carton and/or during transportation of the shelf carton. Users should cease usage of the affected lots immediately due to the potential sterility breach.

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

Brand: Olympus Medical, Olympus Medical Single Use Electrosurgical Snare Sd-400.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

78388

Classification

Type 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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