Health product recall

EZDilate™ Balloon Dilator (WG)

Brand(s)
Last updated

Summary

Product
EZDilate™ Balloon Dilator (WG)
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

EZDilate™ Balloon Dilator (WG)

408987

BD-410X-1055

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Ear, nose and throat
Companies

Gyrus ACMI, Inc

9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76204

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