Class II

Medical Device Recall: EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-1055

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

2991 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0940-2024

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.