Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1905-2026·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-2117) 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 of a medical device with no reported injuries or illnesses. The hazard—premature failure of locking mechanism—represents a potential functional defect that could affect device performance, but no adverse health consequences have been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling 1,929 units of OER-ELITE Endoscope Reprocessor Connecting Tubes (Model/Catalog Number MAJ-2117) due to a potential for the Version 2 reprocessor connecting tube lock levers to fail prematurely.

The connecting tubes are used in endoscope reprocessing systems. Failure of the lock levers could affect the proper connection and secure fastening of the tubes during reprocessing procedures.

The affected product has been distributed worldwide, including across the United States and Canada, China, Hong Kong, Japan, South Korea, and Taiwan. The recalled units include specific lot numbers ranging from 09A through 51A, with UDI Number 04953170404122.

Users of this medical device should contact Olympus Corporation of the Americas for information about replacement units or further guidance on safe use of affected equipment.

The recalled product

Product: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Endoscope Reprocessing Equipment
Hazard: mechanical-failure
lock-lever-failure
Affected units: 1,929

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-2117. UDI Number: 04953170404122. Lot Numbers: 09A
0XA
0YA
0ZA
11A
12A
24A
25A
26A
27A
28A
29A
2XA
2YA
2ZA
31A
32A
33A
34A
35A

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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