OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2110) because the Version 2 reprocessor connecting tube lock levers may fail prematurely. The tubes are used to reprocess endoscopes.
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 a Class II medical device recall with no reported injuries or adverse events stated in the source. The hazard is a potential premature lock lever failure, which represents a device defect requiring remedy but without documented harm or hospitalization reports.
Plain-English summary
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes, Model Number MAJ-2110, because the Version 2 reprocessor connecting tube lock levers may fail prematurely. These connecting tubes may be included with the Olympus OER-ELITE reprocessor system and are used to process and reprocess endoscopes for medical use.
Approximately 9,757 units have been distributed worldwide, including across the United States, Canada, China, Hong Kong, Japan, South Korea, and Taiwan. The affected lot numbers are: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 22A, 23A, 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, 51A.
Users of affected connecting tubes should contact Olympus Corporation of the Americas for further instructions, replacement, or remediation.
The recalled product
- Product
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- equipment-failure
- lock-mechanism-failure
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-2110. UDI Number: 04953170404054. Lot Numbers: 09A
- 0XA
- 0YA
- 0ZA
- 11A
- 12A
- 22A
- 23A
- 24A
- 25A
- 26A
- 27A
- 28A
- 29A
- 2XA
- 2YA
- 2ZA
- 31A
- 32A
- 33A
Distribution
Distributed nationwide across the United States.
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