OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2113) because the Version 2 reprocessor connecting tube lock levers may fail prematurely. The defect could affect proper connection during endoscope reprocessing.
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 a mechanical defect (lock lever failure) that could prevent proper device function, which qualifies as a moderate risk without evidence of actual harm.
Plain-English summary
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes, Model MAJ-2113, distributed worldwide including the United States, Canada, China, Hong Kong, Japan, South Korea, and Taiwan. A total of 8,936 units are affected.
The connecting tube lock levers in the Version 2 reprocessor may fail prematurely. This defect could prevent proper connection or secure attachment of the tubes during endoscope reprocessing.
Users who have received affected units should stop using them immediately and contact Olympus Corporation of the Americas for further instructions or a replacement. Affected lot numbers include 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 (UDI: 04953170404085).
The recalled product
- Product
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- mechanical-failure
- device-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-2113. UDI Number: 04953170404085. 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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