Olympus Corporation of the Americas: Medical Device Recall in 2024 - (Recall #: Z-0940-2024)

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 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

Product Classification:

Class II

Date Initiated: November 10, 2023

Date Posted: February 7, 2024

Recall Number: Z-0940-2024

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: 2991 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated