Olympus recalls OER-Elite Endoscope Reprocessors due to potential incorrect assembly causing detergent and alcohol mix-ups, risking ineffective cleaning and patient exposure to residual detergent.
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
Take action
Contact the company
📍Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229
“Olympus OER-Elite Endoscope Reprocessor Recall: Incorrect Assembly Risks Ineffective.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61436-olympus-oer-elite-endoscope-reprocessor-recall-incorrect-assembly-risks-ineffective. Based on FDA recall #Z-0638-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0638-2022%22&limit=1).
The FDA announced on 2021-12-13 that Olympus Corporation of the Americas is recalling the OER-Elite Endoscope Reprocessor due to a hazard involving incorrect tubing assembly. This defect may result in ineffective endoscope reprocessing and patient exposure to residual detergent.
How to tell if you have it
Brand: Olympus
Product: OER-Elite Endoscope Reprocessor
Serial numbers: All serial numbers
UDI: 04953170404047
Quantity: 295 units
The hazard
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.
Context
GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since 2017-08-18. Other recent recalls include the Olympus Tripp-Lite P580-025 DisplayPort Cable (2026-08-27), the Olympus M3 Gold Autoclavable Lateral Telescope 70 (2026-08-24), and the Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector (2026-08-19). Other recent recalls of similar products include the Olympus OER-Elite Recall: Safety Warnings and Maintenance Cautions (2025-10-31), the Olympus OER-Pro Recall: Safety Warnings and Maintenance Cautions (2025-10-31), and the Medtronic Octopus Nuvo Tissue Stabilizer Recall: Incorrect Tube Assembly (2026-01-13).
How to tell if you have this one
The OER-Elite Endoscope Reprocessor is used for cleaning heat-sensitive Olympus flexible endoscopes. All units with serial numbers listed in the recall (UDI: 04953170404047) are affected.
Brand
Olympus
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Assembly
Verify that the detergent and alcohol tank tubing is correctly assembled to ensure proper solution dispensing.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0638-2022 (December 13, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0638-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.