Official recall notice

FDA DeviceClass IINotable

Olympus EZDilate Endoscopic Balloon Dilator Recall (Sep 2026)

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

Recall date
2026-09-30
FDA class
Class II

Why it was recalled

Hazard

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,

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Product description

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,

Affected products

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

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