Recall Ledger

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112 recall (Olympus Corporation of the Americas)

Medical deviceClass IIOngoing

Summary: Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112. Reason: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

What is being recalled

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112

Why

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.

How to tell if yours is affected

Model Number: MAJ-2112. UDI Number: 04953170404078. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 21A, 22A, 23A, 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.

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-1900-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedMarch 25, 2026
ReportedApril 29, 2026
CompanyOlympus Corporation of the Americas
Company locationCenter Valley, PA, United States
Initiated byVoluntary: Firm initiated
Quantity8,994 units

More recalls from Olympus Corporation of the Americas · all medical device recalls · recalls from March 2026

Official FDA record