Official recall record

EZDilate™ Balloon Dilator (WG)

Health Canada — Medical Devices · 2024-09-25 · CanadaType II

Issuing authority: Health Canada — Medical Devices
Published: 2024-09-25
Country of alert: Canada
Alert level: Type II
Alert type: recall

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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