Home / Recalls / Olympus Corporation of the Americas / Z-0943-2024

Z-0943-2024 Class II Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
February 7, 2024
Initiation Date
November 10, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4182 units

Product Description

EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1855

Reason for Recall

Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.

Distribution Pattern

Nationwide. Foreign: AU BR BR CA DE HK IN JP SG

Code Information

UDI-DI: 00821925033269 Lot Numbers: 360769, 360770, 368258, 368259, 368844, 369417, 385724, 387425, 387426, 387794, 387795

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