OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2112) 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 illnesses, injuries, or hospitalizations related to the premature lock lever failure, making this a moderate precautionary recall rather than severe.
Plain-English summary
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes, Model Number MAJ-2112, distributed worldwide including US nationwide and Canada, China, Hong Kong, Japan, South Korea, and Taiwan. Approximately 8,994 units are affected across multiple lot numbers (09A through 51A).
The lock levers on the Version 2 reprocessor connecting tubes may fail prematurely, which could compromise the proper function of the endoscope reprocessor system. The affected product is classified as FDA Class II.
Customers who have purchased this product should contact Olympus Corporation of the Americas for instructions on replacement or remediation of the affected units.
The recalled product
- Product
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 8,994
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-2112. UDI Number: 04953170404078. Lot Numbers: 09A
- 0XA
- 0YA
- 0ZA
- 11A
- 12A
- 21A
- 22A
- 23A
- 24A
- 25A
- 26A
- 27A
- 28A
- 29A
- 2XA
- 2YA
- 2ZA
- 31A
- 32A
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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