Olympus Corporation of the Americas OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
All serial numbers. UDI: 04953170404047
Products Sold
All serial numbers. UDI: 04953170404047
Olympus Corporation of the Americas is recalling OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Ol due to The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be di. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Olympus issued Urgent Medical Device Correction letter dated 12/13/21. Letter states reason for recall, health risk and action to take: 1. Please immediately perform an inspection of your installed OER-Elite units as described in the Attachment 1 Alcohol Rinse Inspection . If you require assistance, please contact your local Endoscopy Support Specialist (ESS). 2. If the inspection check does not pass, stop using the OER-Elite and endoscopes reprocessed with that OER-Elite. Contact Olympus TAC at 1-800-848-9024, option 1 for further instruction. If the inspection check passes, you may continue to use your OER-Elite. 3. Access the Olympus recall portal to indicate that you have received this notification and to report the results of the inspection. Go to https://olympusamerica.com/recall. Enter the recall number "0404" and provide your contact information as indicated in the portal. An Olympus Endoscopy Support Specialist (ESS) will reach out to you to schedule an on-site inspection of the OER-Elite detergent and alcohol tubing assembly for final confirmation. If you do not know your local ESS, please contact our Olympus TAC at 1-800-848-9024 to connect you with your local ESS. In addition, if you have further distributed this product, please reach out to those facilities and notify them at once of this field action and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this field action notification letter. If you require additional information, please do not hesitate to contact me at Cynthia.Ow@Olympus.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026