The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1902-2026·Announced 2026-04-29

OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure Risk

Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2114) because the Version 2 reprocessor connecting tube lock levers may fail prematurely, potentially affecting equipment operation and patient safety 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 medical device recall. The source text does not report any illnesses, injuries, or confirmed failures—only a potential for premature lock lever failure. The hazard is theoretical rather than confirmed, and no adverse health consequences are documented, placing this within the Moderate range for a Class II device with precautionary intent.

Plain-English summary

Olympus Corporation of the Americas is recalling the OER-ELITE Endoscope Reprocessor Connecting Tubes, Model Number MAJ-2114. Approximately 2,143 units have been distributed worldwide, including throughout the US and in Canada, China, Hong Kong, Japan, South Korea, and Taiwan.

The Version 2 reprocessor connecting tube lock levers may fail prematurely. This failure could compromise the equipment's ability to properly secure and reprocess endoscopes, potentially affecting the safety and efficacy of endoscope reprocessing procedures.

Customers using the affected connecting tubes should stop use and contact Olympus Corporation of the Americas for further instructions. Healthcare facilities should verify whether they have received connecting tubes from the affected lot numbers (09A, 0XA, 0YA, 0ZA, 11A, 12A, 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, 51A) and take appropriate action.

The recalled product

Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Endoscope Reprocessing Equipment
Hazard
Affected units
2,143

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-2114. UDI Number: 04953170404092. 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 →

Related recalls

Same manufacturer · Olympus Corporation of the Americas

See all →

Same hazard · equipment malfunction

See all →

Similar recalls