FDA-Device2026-09-30Class II
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
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,
Sold states
International distribution in the country of Japan.
Affected count
305 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3216-2026More Olympus recalls
- FDA-Device2026-09-30Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.
- FDA-Device2026-09-30Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.
- FDA-Device2026-09-30Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.
- FDA-Device2026-09-30Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.
- FDA-Device2026-07-29Olympus OEV321UH 4K UHD LCD Monitor recalled for faulty HDMI and DisplayPort connectors
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.