FDA-Device2024-02-07Class II
EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1880
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
5031 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1880
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0937-2024More Olympus Corporation of the Americas recalls
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- FDA-Device2026-04-01Olympus MAJ-1443 and MAJ-1444 endoscope suction valves no longer compatible with OER-Pro and OER-Elite reprocessors
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
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