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The official notice did not include a photo. Check the product details and identifiers below.
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An official Health Canada notice concerns Ezdilate balloon dilators. 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 Published 2023-12-04.
What to do now
Contact the manufacturer if you require additional information.
Recall number
74670
Official notice
2023-12-04
The hazard
The hazard
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
How to check if you're affected
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
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Turn on recall alertsAffected products
Affected products
Product 1
Product 2
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Gyrus Acmi, Ezdilate Balloon Dilators.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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