Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2138) due to potential premature failure of the Version 2 reprocessor connecting tube lock levers. The defect could affect proper tube attachment 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. The source text describes a potential for premature failure of lock levers but does not report any actual illnesses, injuries, or adverse events. The hazard is a mechanical malfunction with theoretical risk rather than confirmed harm, consistent with a Moderate severity classification.
Plain-English summary
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes, Model Number MAJ-2138, used in endoscope reprocessing systems. The Version 2 reprocessor connecting tube lock levers may fail prematurely, potentially compromising the secure attachment of connecting tubes during the reprocessing cycle.
A total of 808 units have been distributed worldwide, including throughout the US and Canada, China, Hong Kong, Japan, South Korea, and Taiwan. The affected lot numbers are: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 24A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 4ZA, and 51A. The UDI Number is 04953170404184.
Facilities that have received these connecting tubes should cease use of affected units and contact Olympus Corporation of the Americas for instructions on replacement or return. For additional information, the FDA recall notification is available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-1908-2026.
The recalled product
- Product
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- device-malfunction
- failed-lock-mechanism
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-2138. UDI Number: 04953170404184. Lot Numbers: 09A
- 0XA
- 0YA
- 0ZA
- 11A
- 12A
- 24A
- 25A
- 26A
- 27A
- 28A
- 29A
- 2XA
- 2YA
- 3XA
- 3YA
- 3ZA
- 41A
- 42A
- 43A
Distribution
Distributed nationwide across the United States.
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