Home / Recalls / Olympus Corporation of the Americas / Z-0934-2024

Z-0934-2024 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
1796 units

Product Description

EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1080

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: 00821925033177 Lot Numbers: 366479, 384325, 384502

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