OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2111) 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 with no reported illnesses or injuries. The hazard is mechanical failure of a component in a medical device used in controlled healthcare settings, which constitutes a moderate-level concern that does not meet the thresholds for High or above.
Plain-English summary
Olympus Corporation of the Americas is recalling approximately 10,141 units of the OER-ELITE Endoscope Reprocessor Connecting Tubes, Model MAJ-2111. The Version 2 reprocessor connecting tube lock levers may fail prematurely, potentially affecting the function of the reprocessor.
The affected units were distributed worldwide, including throughout the United States and in Canada, China, Hong Kong, Japan, South Korea, and Taiwan. The recall includes multiple lot numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 22A, 24A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 2ZA, 31A, 32A, 33A, 34A, 35A, 36A, 37A, 38A, 39A, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 4ZA, and 51A.
Healthcare facilities using the affected connecting tubes should contact Olympus Corporation of the Americas for further instructions regarding the premature lock lever failure issue and replacement or remedy options.
The recalled product
- Product
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- mechanical-failure
- device-defect
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-2111. UDI Number: 04953170404061. Lot Numbers: 09A
- 0XA
- 0YA
- 0ZA
- 11A
- 12A
- 22A
- 24A
- 25A
- 26A
- 27A
- 28A
- 29A
- 2XA
- 2YA
- 2ZA
- 31A
- 32A
- 33A
- 34A
Distribution
Distributed nationwide across the United States.
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