FDA DeviceClass IINotable

FDA Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.

Date: 2026-04-29
Brand: Olympus Corporation of the Americas
Category: Medical Device
FDA Class: Class II

Description

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

Hazard

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

Remedy

373 units

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