OER-Elite Endoscope Reprocessor-for use in cleaning and recall
OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and…
Why was OER-Elite Endoscope Reprocessor-for use in cleaning and 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All serial numbers. UDI: 04953170404047
- Product
- OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 295 units
- Distribution
- Nationwide
- Recall date
- February 23, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)