Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2116) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
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: FDA Class II recall of a medical device where a mechanical failure (lock lever failure) poses a risk of harm if the connecting tubes disconnect during endoscope reprocessing, which could compromise infection control. No illnesses or injuries are reported in the source text, but the nature of the defect and the critical context of use (sterilization/reprocessing equipment) indicate potential for serious patient harm.
Plain-English summary
Olympus Corporation of the Americas is recalling 373 units of OER-ELITE Endoscope Reprocessor Connecting Tubes, Model MAJ-2116, due to a potential defect: the Version 2 reprocessor connecting tube lock levers may fail prematurely.
The affected units have been distributed worldwide, including nationwide in the United States and internationally to Canada, China, Hong Kong, Japan, South Korea, and Taiwan. The affected lot numbers are: 09A, 0XA, 0YA, 0ZA, 11A, 25A, 26A, 27A, 28A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, and 51A (UDI Number: 04953170404115).
Patients or healthcare providers who use or have used this device should contact Olympus Corporation of the Americas for instructions on inspection, repair, or replacement of the affected connecting tubes.
The recalled product
- Product
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- mechanical-failure
- equipment-malfunction
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 (17)
- Model: MAJ-2116. UDI Number: 04953170404115. Lot Numbers: 09A
- 0XA
- 0YA
- 0ZA
- 11A
- 25A
- 26A
- 27A
- 28A
- 45A
- 46A
- 47A
- 48A
- 49A
- 4XA
- 4YA
- 51A.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModerateSilastic Brand Foley Catheters recalled due to surface stain
FDA (Devices) · 2026-05-27
- HighIntegris-Allura X-ray systems with degraded deaeration hoses recalled
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 13FR Model 94913L Recall
FDA (Devices) · 2026-05-27