OER-ELITE Endoscope Reprocessor Connecting Tubes Recalled Nationwide
Olympus Corporation recalls OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2115) due to a defect. The recall affects approximately 2,089 units distributed nationwide and internationally.
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 voluntary recall with no reported illnesses or injuries. Class II recalls do not automatically meet the threshold for "High" severity, and the absence of reported harm and undisclosed hazard specifics places this in the Moderate category.
Plain-English summary
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes, Model Number MAJ-2115. The recall affects approximately 2,089 units distributed nationwide and to Canada, China, Hong Kong, Japan, South Korea, and Taiwan.
The source material does not specify the nature of the defect or hazard associated with these connecting tubes. The reason for recall is listed as undisclosed in the official notice.
Customers who have received affected units (Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 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, 51A) should contact Olympus Corporation of the Americas at 3500 Corporate Parkway, Center Valley, PA 18034-8229 for further instructions. This is a voluntary recall initiated by the manufacturer.
The recalled product
- Product
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- defect
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-2115. UDI Number: 04953170404108. Lot Numbers: 09A
- 0XA
- 0YA
- 0ZA
- 11A
- 12A
- 25A
- 26A
- 27A
- 28A
- 29A
- 2XA
- 2YA
- 2ZA
- 31A
- 32A
- 33A
- 34A
- 35A
- 36A
Distribution
Distributed nationwide across the United States.
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