Olympus Corporation of the Americas: Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100

Hazard

The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover could include the risk of aspiration, inhalation, or obstruction that will require urgent removal, and/or burns from an uncovered distal end.

Details from the source

Reason for recall: The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover could include the risk of aspiration, inhalation, or obstruction that will require urgent removal, and/or burns from an uncovered distal end. Distribution: US Nationwide. Quantity: 309278 pieces Lot/code info: UDI-DI: 04953170403019; Item code: Catalog N5786100 Lots Lower than H2530

UPC codes

04953170403019

Source

Official record: FDA (Device enforcement) ↗

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