Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recalled
Olympus Corporation is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2118) due to potential premature failure of Version 2 reprocessor connecting tube lock levers. The recall affects 1,259 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classified this as Class II, and the source explicitly states a potential defect (lock lever failure) in a medical device used in patient procedures. Although no reported illnesses or injuries are stated in the source, the risk-of-harm inherent in equipment malfunction during endoscope reprocessing—which is critical to patient safety—meets the High threshold.
Plain-English summary
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes, Model/Catalog Number MAJ-2118. The recall involves 1,259 units that have been distributed worldwide, including to the United States and Canada, China, Hong Kong, Japan, South Korea, and Taiwan. The UDI number is 04953170404139.
The connecting tubes are being recalled because the Version 2 reprocessor connecting tube lock levers may fail prematurely. This potential failure could affect the proper functioning of the endoscope reprocessor.
Healthcare facilities and clinics that have received these connecting tubes should contact Olympus Corporation of the Americas for instructions on replacement or further guidance. Affected lot numbers include: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 23A, 24A, 25A, 26A, 27A, 28A, 2YA, 34A, 35A, 36A, 37A, 38A, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 4ZA, and 51A.
The recalled product
- Product
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
- 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-2118. UDI Number: 04953170404139. Lot Numbers: 09A
- 0XA
- 0YA
- 0ZA
- 11A
- 12A
- 23A
- 24A
- 25A
- 26A
- 27A
- 28A
- 2YA
- 34A
- 35A
- 36A
- 37A
- 38A
- 3XA
- 3YA
Distribution
Distributed nationwide across the United States.
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