Device recall

Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.

FDA recall source

Recall number

Z-3216-2026

Event id

99627

Status

Ongoing

FDA classification

Class II

Recalling firm

Olympus Corporation of the Americas

Report date

Sep 30, 2026

Posted

Sep 18, 2026

Initiated

Aug 19, 2026

Center classification date

Sep 18, 2026

Product code

FGE

Device type

Stents, Drains And Dilators For The Biliary Ducts

Reason

Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,

Root cause

Process control

Quantity

305 units

Code info

Model Number: BD-420X-1355. UDI-DI: 00821925042261. Lot Number: 460898.

Distribution

International distribution in the country of Japan.

Voluntary or mandated

Voluntary: Firm initiated

Location

Center Valley, PA, United States