The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1908-2026·Announced 2026-04-29

Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall

Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2138) due to potential premature failure of the Version 2 reprocessor connecting tube lock levers. The defect could affect proper tube attachment during endoscope reprocessing.

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. The source text describes a potential for premature failure of lock levers but does not report any actual illnesses, injuries, or adverse events. The hazard is a mechanical malfunction with theoretical risk rather than confirmed harm, consistent with a Moderate severity classification.

Plain-English summary

Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes, Model Number MAJ-2138, used in endoscope reprocessing systems. The Version 2 reprocessor connecting tube lock levers may fail prematurely, potentially compromising the secure attachment of connecting tubes during the reprocessing cycle.

A total of 808 units have been distributed worldwide, including throughout the US and Canada, China, Hong Kong, Japan, South Korea, and Taiwan. The affected lot numbers are: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 24A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 4ZA, and 51A. The UDI Number is 04953170404184.

Facilities that have received these connecting tubes should cease use of affected units and contact Olympus Corporation of the Americas for instructions on replacement or return. For additional information, the FDA recall notification is available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-1908-2026.

The recalled product

Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Endoscope Reprocessor Equipment
Hazard
Affected units
808

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-2138. UDI Number: 04953170404184. Lot Numbers: 09A
  • 0XA
  • 0YA
  • 0ZA
  • 11A
  • 12A
  • 24A
  • 25A
  • 26A
  • 27A
  • 28A
  • 29A
  • 2XA
  • 2YA
  • 3XA
  • 3YA
  • 3ZA
  • 41A
  • 42A
  • 43A

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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