Class II

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

Olympus Corporation of the Americas · August 19, 2026

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.

States Affected

IN

Quantity Affected

305 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3216-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Olympus Corporation of the Americas Medical Device Recall: Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355. | SafeCheck