Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2117) 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 of a medical device with no reported injuries or illnesses. The hazard—premature failure of locking mechanism—represents a potential functional defect that could affect device performance, but no adverse health consequences have been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling 1,929 units of OER-ELITE Endoscope Reprocessor Connecting Tubes (Model/Catalog Number MAJ-2117) due to a potential for the Version 2 reprocessor connecting tube lock levers to fail prematurely.
The connecting tubes are used in endoscope reprocessing systems. Failure of the lock levers could affect the proper connection and secure fastening of the tubes during reprocessing procedures.
The affected product has been distributed worldwide, including across the United States and Canada, China, Hong Kong, Japan, South Korea, and Taiwan. The recalled units include specific lot numbers ranging from 09A through 51A, with UDI Number 04953170404122.
Users of this medical device should contact Olympus Corporation of the Americas for information about replacement units or further guidance on safe use of affected equipment.
The recalled product
- Product
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 1,929
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-2117. UDI Number: 04953170404122. 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.
Part of a larger recall action
This product is one of 12 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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