Olympus Corporation of the Americas: EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model:

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.

Details from the source

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 Quantity: 3767 units Lot/code info: UDI-DI: 00821925033252 Lot Numbers: 372741, 373098, 373607, 378931, 378932, 380775, 380776, 387128, 388778, 388779, 389197, 389201

UPC codes

00821925033252

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.