Home / Recalls / Olympus Corporation of the Americas / Z-0937-2024

Z-0937-2024 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
5031 units

Product Description

EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1880

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: 00821925033191 Lot Numbers: 365375, 365823, 365824, 365825, 369028, 382273, 382350, 382351, 383160 Added 12/1/23: 376575, 376888,376914

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