Class II

Medical Device Recall: 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 · November 10, 2023

Reason for Recall

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.

Distribution

Nationwide. Foreign: AU BR BR CA DE HK IN JP SG

States Affected

NATIONWIDE

Quantity Affected

5232 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0936-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Olympus Corporation of the Americas Medical Device Recall: 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 | SafeCheck