OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Levers Failure Risk
Olympus Corporation is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2330) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text does not report any hospitalizations, injuries, or illnesses resulting from the lock lever failure, making this a moderate-severity precautionary recall rather than a severe one.
Plain-English summary
Olympus Corporation of the Americas is recalling the OER-ELITE Endoscope Reprocessor Connecting Tubes, Model Number MAJ-2330, due to a potential for the Version 2 reprocessor connecting tube lock levers to fail prematurely. The affected product was distributed worldwide, including US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea, and Taiwan. Approximately 1,829 units are affected across multiple lot numbers.
Patients and healthcare facilities using this equipment should contact Olympus Corporation of the Americas for guidance on inspection and replacement if necessary. This is a Class II recall issued by the FDA.
The recalled product
- Product
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 1,829
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 (20)
- Model Number: MAJ-2330. UDI Number: 04953170404207. Lot Numbers: 09A
- 0XA
- 0YA
- 0ZA
- 11A
- 12A
- 24A
- 25A
- 26A
- 27A
- 28A
- 29A
- 2XA
- 2YA
- 2ZA
- 31A
- 32A
- 33A
- 34A
- 35A
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 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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