Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of Recalled by Olympus Corporation of the Americas Due to Foreign Object Contamination
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Olympus Corporation of the Americas directly.
Affected 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
Quantity: 5031 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Olympus Corporation of the Americas
Olympus Corporation of the Americas has 378 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report