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

Medical DevicesSource: FDA (device) · Date: 2026-09-30

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Olympus Corporation of the Americas
Product
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
Reason / 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,
Classification
Class II
Status
Ongoing
Distribution / sold at
International distribution in the country of Japan.
Recall initiated
2026-08-19
Code info
Model Number: BD-420X-1355. UDI-DI: 00821925042261. Lot Number: 460898.
Product quantity
305 units
Voluntary mandated
Voluntary: Firm initiated
City
Center Valley
State
PA
Country
United States
Event id
99627
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