The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1903-2026·Announced 2026-04-29

OER-ELITE Endoscope Reprocessor Connecting Tubes Recalled Nationwide

Olympus Corporation recalls OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2115) due to a defect. The recall affects approximately 2,089 units distributed nationwide and internationally.

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 voluntary recall with no reported illnesses or injuries. Class II recalls do not automatically meet the threshold for "High" severity, and the absence of reported harm and undisclosed hazard specifics places this in the Moderate category.

Plain-English summary

Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes, Model Number MAJ-2115. The recall affects approximately 2,089 units distributed nationwide and to Canada, China, Hong Kong, Japan, South Korea, and Taiwan.

The source material does not specify the nature of the defect or hazard associated with these connecting tubes. The reason for recall is listed as undisclosed in the official notice.

Customers who have received affected units (Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 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, 51A) should contact Olympus Corporation of the Americas at 3500 Corporate Parkway, Center Valley, PA 18034-8229 for further instructions. This is a voluntary recall initiated by the manufacturer.

The recalled product

Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Endoscope Reprocessing Equipment
Hazard
Affected units
2,089

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-2115. UDI Number: 04953170404108. Lot Numbers: 09A
  • 0XA
  • 0YA
  • 0ZA
  • 11A
  • 12A
  • 25A
  • 26A
  • 27A
  • 28A
  • 29A
  • 2XA
  • 2YA
  • 2ZA
  • 31A
  • 32A
  • 33A
  • 34A
  • 35A
  • 36A

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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