medical Class II Updated 2024-02-07

Olympus Corporation of the Americas recalls EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic

Recalled Product

EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-0855


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 00821925033221 Lot Numbers: 373808, 374005, 379746, 379747, 379835, 379836, 381157
View official government recall

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