PlainRecalls
FDA Devices Moderate Class II Terminated

OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories

Reported: February 23, 2022 Initiated: December 13, 2021 #Z-0638-2022

Product Description

OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories

Reason for Recall

The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent will be dispensed instead of alcohol for the alcohol cycle, resulting in a ineffective endoscope reprocessing and patient exposure to residual detergent

Details

Units Affected
295 units
Distribution
Nationwide
Location
Center Valley, PA

Frequently Asked Questions

What product was recalled?
OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Recalled by Olympus Corporation of the Americas. Units affected: 295 units.
Why was this product recalled?
The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent will be dispensed instead of alcohol for the alcohol cycle, resulting in a ineffective endoscope reprocessing and patient exposure to residual detergent
Which agency issued this recall?
This recall was issued by the FDA Devices on February 23, 2022. Severity: Moderate. Recall number: Z-0638-2022.