Endoscope Reprocessor Tubing Assembly Error May Reduce Disinfection Effectiveness
Olympus OER-Elite Endoscope Reprocessors may have incorrectly assembled detergent and alcohol tank tubing, causing solutions to be dispensed in reversed cycles. This results in ineffective endoscope disinfection and potential patient exposure to residual detergent.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall. The defect impairs endoscope disinfection, creating a risk of patient infection and chemical exposure. No illnesses or injuries reported. Meets the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Olympus Corporation of the Americas is recalling the OER-Elite Endoscope Reprocessor due to a potential defect in tubing assembly. The detergent and alcohol tank tubing in affected units may have been incorrectly assembled during manufacturing.
If the tubing is incorrectly assembled, the reprocessor will dispense alcohol during the detergent cleaning cycle and detergent during the alcohol disinfection cycle. This reversal prevents effective endoscope disinfection and results in patient exposure to residual detergent during subsequent procedures.
The recall affects 295 units distributed nationwide. Healthcare providers using the OER-Elite Endoscope Reprocessor should contact Olympus Corporation of the Americas to verify proper tubing assembly and obtain instructions for verification, repair, or replacement.
The recalled product
- 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
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 295
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers. UDI: 04953170404047
Distribution
Distributed nationwide across the United States.
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