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Single use ligating device polyloop™

Official notice

7 Nov 2025

MediumHealth Canada

An official Health Canada notice concerns Single use ligating device polyloop™. Olympus received complaints indicating that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally anchored in place around patient anatomy. Users are reminded to adhere to the warnings and cautions statements that are present in the instructions for use. Published 2025-11-07.

What to do now

Contact the manufacturer if you require additional information.

Recall number

78470

Official notice

2025-11-07

The hazard

Olympus received complaints indicating that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally anchored in place around patient anatomy. Users are reminded to adhere to the warnings and cautions statements that are present in the instructions for use.

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

78470

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Affected products

Product 1

Affected products - Single Use Ligating Device PolyLoop™, Lot or serial number - All lots., Model or catalogue number - HX-400U-30

Risk / hazard

Olympus received complaints indicating that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally anchored in place around patient anatomy. Users are reminded to adhere to the warnings and cautions statements that are present in the instructions for use.

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: Olympus Medical, Single Use Ligating Device Polyloop™.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

78470

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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