OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure Risk
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2114) because the Version 2 reprocessor connecting tube lock levers may fail prematurely, potentially affecting equipment operation and patient safety 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 medical device recall. The source text does not report any illnesses, injuries, or confirmed failures—only a potential for premature lock lever failure. The hazard is theoretical rather than confirmed, and no adverse health consequences are documented, placing this within the Moderate range for a Class II device with precautionary intent.
Plain-English summary
Olympus Corporation of the Americas is recalling the OER-ELITE Endoscope Reprocessor Connecting Tubes, Model Number MAJ-2114. Approximately 2,143 units have been distributed worldwide, including throughout the US and in Canada, China, Hong Kong, Japan, South Korea, and Taiwan.
The Version 2 reprocessor connecting tube lock levers may fail prematurely. This failure could compromise the equipment's ability to properly secure and reprocess endoscopes, potentially affecting the safety and efficacy of endoscope reprocessing procedures.
Customers using the affected connecting tubes should stop use and contact Olympus Corporation of the Americas for further instructions. Healthcare facilities should verify whether they have received connecting tubes from the affected lot numbers (09A, 0XA, 0YA, 0ZA, 11A, 12A, 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) and take appropriate action.
The recalled product
- Product
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- equipment-malfunction
- lock-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-2114. UDI Number: 04953170404092. Lot Numbers: 09A
- 0XA
- 0YA
- 0ZA
- 11A
- 12A
- 24A
- 25A
- 26A
- 27A
- 28A
- 29A
- 2XA
- 2YA
- 2ZA
- 31A
- 32A
- 33A
- 34A
- 35A
Distribution
Distributed nationwide across the United States.
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