Class IIDeviceOngoing

Olympus Corporation of the Americas

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,

Details

Recall number: Z-3216-2026
Event ID: 99627
Recall initiated: Aug 19, 2026
Classified: Sep 18, 2026
Reported: Sep 30, 2026
Quantity: 305 units
Distribution: International distribution in the country of Japan.
Initiated by: Voluntary: Firm initiated
Firm notification: E-Mail
Firm location: Center Valley, PA, United States
Lot / code info: Model Number: BD-420X-1355. UDI-DI: 00821925042261. Lot Number: 460898.