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

Official product recall notices and clearly labeled enforcement reference records.

Reference record — not a live warning · enforcement-reference · official-source

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,

Provider: FDA — device enforcement reference
Source observed: 8/19/2026, 12:00:00 AM UTC
Source updated: 9/18/2026, 12:00:00 AM UTC
Location: Center Valley, PA, US
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,
notice: Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.
product: Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
distribution: International distribution in the country of Japan.
event number: 99627
manufacturer: Olympus Corporation of the Americas
recall number: Z-3216-2026
source status: Open, Classified
freshness minutes: 180

Source use policy · openFDA reference data; not a real-time public alert service

Update history (1 recent revisions)