Home / Recalls / Olympus Corporation of the Americas / Z-0940-2024

Z-0940-2024 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
2991 units

Product Description

EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-1055

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:00821925033238 Lot Numbers: 361663, 361664, 365174, 374533, 374534, 375148, 378070, 386123, 386124, 386395

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