Agency classClass IIOur severity:High FDA (Devices)·Z-1906-2026·Announced 2026-04-29

Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recalled

Olympus Corporation is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2118) due to potential premature failure of Version 2 reprocessor connecting tube lock levers. The recall affects 1,259 units distributed worldwide.

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: The FDA classified this as Class II, and the source explicitly states a potential defect (lock lever failure) in a medical device used in patient procedures. Although no reported illnesses or injuries are stated in the source, the risk-of-harm inherent in equipment malfunction during endoscope reprocessing—which is critical to patient safety—meets the High threshold.

Plain-English summary

Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes, Model/Catalog Number MAJ-2118. The recall involves 1,259 units that have been distributed worldwide, including to the United States and Canada, China, Hong Kong, Japan, South Korea, and Taiwan. The UDI number is 04953170404139.

The connecting tubes are being recalled because the Version 2 reprocessor connecting tube lock levers may fail prematurely. This potential failure could affect the proper functioning of the endoscope reprocessor.

Healthcare facilities and clinics that have received these connecting tubes should contact Olympus Corporation of the Americas for instructions on replacement or further guidance. Affected lot numbers include: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 23A, 24A, 25A, 26A, 27A, 28A, 2YA, 34A, 35A, 36A, 37A, 38A, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 4ZA, and 51A.

The recalled product

Product: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Endoscope Reprocessing Equipment
Hazard: equipment-failure
lock-mechanism-failure
Affected units: 1,259

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-2118. UDI Number: 04953170404139. Lot Numbers: 09A
0XA
0YA
0ZA
11A
12A
23A
24A
25A
26A
27A
28A
2YA
34A
35A
36A
37A
38A
3XA
3YA

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 →

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