Olympus Endoscope Reprocessor Labeling Revised for Compatibility and Sterilization Parameters
Olympus is revising labeling for its OER-Elite, OER-Pro, and OER-Mini endoscope reprocessors due to incompatible endoscope models and incorrect sterilization parameters in previous labeling. The revisions remove two endoscope models from the compatibility list and correct gas sterilization concentration requirements.
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: This is an FDA Class II medical device with multiple labeling errors affecting critical safety parameters (endoscope compatibility, sterilization concentration, cleaning tools) that could result in improper disinfection and infection risk if incorrect procedures are followed. No illnesses have been reported, but the risk of harm from improper reprocessing is significant, fitting the criteria for High severity.
Plain-English summary
Olympus Corporation of the Americas is issuing a labeling revision for approximately 1,063 units of its OER-Elite, OER-Pro, and OER-Mini endoscope reprocessors distributed nationwide. The revision addresses errors in the device labeling regarding compatible endoscope models and sterilization procedures.
The revised labeling removes two endoscope models (LF-V and LF-P) that were previously listed as compatible with the reprocessors, as they should not be processed in these devices. Additionally, the labeling now specifies 100% ethylene oxide (EtO) gas sterilization instead of the previously stated 12% EtO concentration. The labeling also notes that reusable cleaning brushes are no longer recommended, with only single-use brushes remaining compatible.
Healthcare facilities using these reprocessors with Olympus endoscopes should verify that they are only processing compatible endoscope models and using the correct sterilization parameters and cleaning tools.
Affected users should obtain updated labeling from Olympus and ensure their reprocessing protocols match the revised instructions.
The recalled product
- Product
- Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 1,063
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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