FDA-Device2024-02-07Class II
EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1580
Olympus Corporation of the Americas
Hazard
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
Sold states
Nationwide. Foreign: AU BR BR CA DE HK IN JP SG
Affected count
5232 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1580
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0936-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief