medical Class II Updated 2024-02-07

Olympus Corporation of the Americas recalls EZDilate Wire Guided Balloon 18-19-20. Indicated for endosc

Recalled Product

EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-2055


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: 00821925033276 Lot Numbers: 366881, 367026, 367030, 369509, 370718, 371173, 372147, 374100, 374101, 374810, 386463, 386841 386842, 387130, 387424
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →