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.
What this means for you
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
- Hazard
- mechanical-failure
- equipment-malfunction
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.
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