Official recall record
EZDilate Balloon Dilators
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2023-12-04
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Olympus is taking this recall action after investigating reported complaints about issues inflating, deflating and/or retrieving the devices, as well as reports of bursting and leaking. Olympus has received reported adverse events involving foreign body in patient and prolonged procedure. Recall Start Date: November 21, 2023
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.
Record last checked against the registry on 2026-05-31.
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