TemporaryFDAOngoing
Can cause harm that is usually temporary.
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
Check the device or its packaging for
Model Number: BD-420X-1355. UDI-DI: 00821925042261. Lot Number: 460898.
- Why
- 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,
- Distributed
- International distribution in the country of Japan.
- Company
- Olympus Corporation of the Americas
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-3216-2026 · retrieved 18 September 2026
Read the official notice