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Ezdilate™ balloon dilator (wg)

Official notice

25 Sept 2024

MediumHealth Canada

An official Health Canada notice concerns Ezdilate™ balloon dilator (wg). Olympus is taking this recall action after having received 4 complaints between March 2024 and June 2024 from customers indicating the balloon was packaged with the incorrect Glo cath label applied to the balloon dilation catheter for the diameter sizes. The incorrect label states 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm. All other labeling is correct for the balloon, including the shelf box with front box label and circular star label and the balloon pouch. Recall start date: September 13, 2024 Published 2024-09-25.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76204

Official notice

2024-09-25

The hazard

Olympus is taking this recall action after having received 4 complaints between March 2024 and June 2024 from customers indicating the balloon was packaged with the incorrect Glo cath label applied to the balloon dilation catheter for the diameter sizes. The incorrect label states 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm. All other labeling is correct for the balloon, including the shelf box with front box label and circular star label and the balloon pouch. Recall start date: September 13, 2024

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

76204

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Affected products

Product 1

Affected products - EZDilate™ Balloon Dilator (WG), Lot or serial number - 408987, Model or catalog number - BD-410X-1055

Risk / hazard

Olympus is taking this recall action after having received 4 complaints between March 2024 and June 2024 from customers indicating the balloon was packaged with the incorrect Glo cath label applied to the balloon dilation catheter for the diameter sizes. The incorrect label states 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm. All other labeling is correct for the balloon, including the shelf box with front box label and circular star label and the balloon pouch. Recall start date: September 13, 2024

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: Gyrus Acmi, Ezdilate™ Balloon Dilator.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

76204

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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