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
Olymp: Olympus is recalling its OER-Elite Endoscope Reprocessors because incorrect assembly of the detergent and alcohol tubing may cause the machine to dispense the wrong solution during cleaning cycles. This could lead to ineffective decontamination and expose patients to residual detergent.
The detergent and alcohol tank tubing may be incorrectly assembled, causing the machine to dispense detergent instead of alcohol or vice versa during cleaning cycles. This results in ineffective endoscope reprocessing and potential patient exposure to residual detergent.
Healthcare facilities using Olympus OER-Elite Endoscope Reprocessors for cleaning heat-sensitive endoscopes are affected. Staff handling endoscopes and patients are at risk if the machine is not properly maintained.
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.
Verify that the detergent and alcohol tank tubing is correctly assembled to ensure proper solution dispensing.
The detergent and alcohol tank tubing may have been incorrectly assembled, causing the machine to dispense the wrong solution during cleaning cycles, which can lead to ineffective decontamination and patient exposure to residual detergent.
Check if the detergent and alcohol tank tubing is correctly assembled. If unsure, contact Olympus Corporation of the Americas for guidance.
The recall does not specify a deadline for correction; users should check assembly and contact Olympus if needed.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0638-2022 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0638-2022 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
