FDA recall Z-3216-2026

Olympus Corporation of the Americas · Class II · device

Product

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

Reason for recall

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,

Distribution

International distribution in the country of Japan.

Key facts

Status
Ongoing
Initiation date
2026-08-19
Report date
2026-09-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3216-2026