Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1899-2026·Announced 2026-04-29

OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure

Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2111) 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 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 an FDA Class II recall with no reported illnesses or injuries. The hazard is mechanical failure of a component in a medical device used in controlled healthcare settings, which constitutes a moderate-level concern that does not meet the thresholds for High or above.

Plain-English summary

Olympus Corporation of the Americas is recalling approximately 10,141 units of the OER-ELITE Endoscope Reprocessor Connecting Tubes, Model MAJ-2111. The Version 2 reprocessor connecting tube lock levers may fail prematurely, potentially affecting the function of the reprocessor.

The affected units were distributed worldwide, including throughout the United States and in Canada, China, Hong Kong, Japan, South Korea, and Taiwan. The recall includes multiple lot numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 22A, 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, and 51A.

Healthcare facilities using the affected connecting tubes should contact Olympus Corporation of the Americas for further instructions regarding the premature lock lever failure issue and replacement or remedy options.

The recalled product

Product: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Endoscope Reprocessing Equipment
Hazard: mechanical-failure
device-defect
Affected units: 10,141

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-2111. UDI Number: 04953170404061. Lot Numbers: 09A
0XA
0YA
0ZA
11A
12A
22A
24A
25A
26A
27A
28A
29A
2XA
2YA
2ZA
31A
32A
33A
34A

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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