Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1898-2026·Announced 2026-04-29

OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure

Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2110) because the Version 2 reprocessor connecting tube lock levers may fail prematurely. The tubes are used to reprocess endoscopes.

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 2/5 (Moderate).

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 a Class II medical device recall with no reported injuries or adverse events stated in the source. The hazard is a potential premature lock lever failure, which represents a device defect requiring remedy but without documented harm or hospitalization reports.

Plain-English summary

Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes, Model Number MAJ-2110, because the Version 2 reprocessor connecting tube lock levers may fail prematurely. These connecting tubes may be included with the Olympus OER-ELITE reprocessor system and are used to process and reprocess endoscopes for medical use.

Approximately 9,757 units have been distributed worldwide, including across the United States, Canada, China, Hong Kong, Japan, South Korea, and Taiwan. The affected lot numbers are: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 22A, 23A, 24A, 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, 4ZA, 51A.

Users of affected connecting tubes should contact Olympus Corporation of the Americas for further instructions, replacement, or remediation.

The recalled product

Product: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Endoscope Reprocessor Equipment
Hazard: equipment-failure
lock-mechanism-failure
Affected units: 9,757

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-2110. UDI Number: 04953170404054. Lot Numbers: 09A
0XA
0YA
0ZA
11A
12A
22A
23A
24A
25A
26A
27A
28A
29A
2XA
2YA
2ZA
31A
32A
33A

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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