OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Failure Recall
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2119) due to potential premature failure of the Version 2 reprocessor connecting tube lock levers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall of a medical device where the source text does not report any illnesses or injuries to date. The potential for premature lock lever failure presents a risk of harm to endoscope reprocessing function, qualifying it as High per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Olympus Corporation of the Americas is recalling 741 units of OER-ELITE Endoscope Reprocessor Connecting Tubes, Model/Catalog Number MAJ-2119. The affected lots are: 09A, 0XA, 0YA, 0ZA, 11A, 14A, 15A, 16A, 17A, 18A, 1XA, 1YA, 1ZA, 22A, 23A, 24A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 2ZA, 31A, 32A, 33A, 34A, 35A, 36A, 37A, 38A, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 4XA, 4YA, and 51A (UDI: 04953170404146).
The Version 2 reprocessor connecting tube lock levers may fail prematurely. This device is used in endoscope reprocessing systems.
The product has been distributed worldwide, including in the United States and Canada, China, Hong Kong, Japan, South Korea, and Taiwan. Healthcare facilities and medical device users who have received this product should contact Olympus Corporation of the Americas for information on identification, replacement, or return of affected units.
The recalled product
- Product
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 741
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-2119. UDI Number: 04953170404146. Lot Numbers: 09A
- 0XA
- 0YA
- 0ZA
- 11A
- 14A
- 15A
- 16A
- 17A
- 18A
- 1XA
- 1YA
- 1ZA
- 22A
- 23A
- 24A
- 25A
- 26A
- 27A
- 28A
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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