EZDilate Balloon Dilators
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
EZDilate Balloon Dilator (FW) |
More than 10 numbers, contact manufacturer. |
BD- 400P-1580 |
EZDilate Balloon Dilator (WG) |
More than 10 numbers, contact manufacturer. |
BD-410X-2055 |
Issue
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
Additional information
Details
Gyrus Acmi, Inc
9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445
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