medical Class II Updated 2024-02-07

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

Recalled Product

EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-2080


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: 00821925033214 Lot Numbers: 364645, 365580, 365582, 365586, 375543, 375973, 381391, 381558, 381559, 381560, 381892, 381893 382697, 382698, 383359, 383360, 383361 Added 12/1/23: 376573, 376574, 376918, 377491
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →