Agency classClass IIOur severity:High FDA (Devices)·Z-1904-2026·Announced 2026-04-29

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.

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: 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
Category: Medical Device — Endoscope Reprocessing Equipment
Hazard: mechanical-failure
equipment-malfunction
Affected units: 373

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.

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.

See all 12 products in this recall →

Same manufacturer · Olympus Corporation of the Americas

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