Olympus OER-Pro Endoscope Reprocessor Recall Issued for Cleaning Instructions
Olympus is recalling OER-Pro endoscope reprocessors because instructions may incorrectly suggest skipping precleaning steps. Users must conduct manual cleaning.
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: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria for potential infection risks from improper cleaning.
Plain-English summary
Olympus Corporation of the Americas is recalling the OER-Pro Endoscope Reprocessor, an endoscope washer/disinfector. The recall involves 2,686 units distributed to 48 states and the District of Columbia. All serial numbers for the OER-Pro model are affected.
The recall is being issued because the device's instructions may indicate that users could forego certain steps in precleaning and manual cleaning of endoscopes. This presents a risk because proper cleaning is essential for the safe use of medical devices.
Users of the OER-Pro Endoscope Reprocessor are required to conduct duodenoscope precleaning and manual cleaning, even when using the automated reprocessor. Users should follow the new warning to ensure all necessary cleaning steps are performed.
The recalled product
- Product
- OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
- Manufacturer
- Olympus Corporation of the Americas
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 (2)
- Model: OER-Pro
- All serial numbers affected
Distribution
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