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FDANovember 10, 2023device

EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-0880

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

00821925033160

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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