Olympus Corporation of the Americas: Medical Device Recall in 2024 - (Recall #: Z-0225-2025)

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- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy. Model/Catalog Number: BD-410X-1055

Product Classification:

Class II

Date Initiated: September 13, 2024

Date Posted: October 30, 2024

Recall Number: Z-0225-2025

Event ID: 95400

Reason for Recall:

Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm and may result in prolonged surgery. All other labeling is correct for the balloon, including the Shelf Box with Front Box Label and Circular Star Label and the balloon Pouch

Status: Ongoing

Product Quantity: 209 units

Code Information:

UDI-DI: 821925033238 Lot: 408987

Distribution Pattern:

Worldwide Distribution: US distribution to states of: CA, FL, IL, NJ, NY, PA, TN, VA, WI; and Foreign OUS to countries of: CA, DE, IN, SG, Latin America.

Voluntary or Mandated:

Voluntary: Firm initiated