Olympus Corporation of the Americas: Medical Device Recall in 2024 - (Recall #: Z-0939-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 10, 2023

Date Posted: February 7, 2024

Recall Number: Z-0939-2024

Event ID: 93508

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.

Status: Ongoing

Product Quantity: 1639 units

Code Information:

UDI-DI: 00821925033221 Lot Numbers: 373808, 374005, 379746, 379747, 379835, 379836, 381157

Distribution Pattern:

Nationwide. Foreign: AU BR BR CA DE HK IN JP SG

Voluntary or Mandated:

Voluntary: Firm initiated