Z-1908-2026Class II

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138

Name: Z-1908-2026 OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138
Creator: Olympus Corporation of the Americas
Published: 2026-03-25
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2026-03-25 / Open, Classified / root cause: design

FDA source

Olympus Corporation of the Americas began a recall of OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138 on 2026-03-25. FDA classified it as Class II and gives the reason as "Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1908-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-25
Posted: 2026-04-22
Recalling firm: OLYMPUS Corporation of the Americas
Product: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
Product code: FEB Accessories, Cleaning, For Endoscope
Reason for recall: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Root cause tag: design
FDA root cause: Device Design
Action: Olympus notified consignees on about 03/25/2026 via letter titled "URGENT: MEDICAL DEVICE REMOVAL." Consignees were notified of the issue and hazard involved and were instructed to examine inventory and OER-ELITE devices for the affected product. The current version has black lock levers. The previous versions have gray lock levers or integrated lock levers, which are the same color as the rest of the connector. Consignees were instructed that if they have sufficient quantities of the current version (black) to support reprocessing needs, stop using the previous version and set aside for return. They may proceed with using the current version, only. If they have insufficient quantities of the current version (black) available, and do not have another method of endoscope reprocessing readily available, they may continue using the previous version(s) consistent with the Instructions for Use, which require users to inspect the connecting tube prior to use. Transition to the current version as soon as possible by placing an order through Customer Service at 1-800-848-9024, option 2. When sufficient quantities of the current version (black) are obtained to support reprocessing needs, stop using the previous version and only use the current version going forward. Then arrange for return the previous version of the connector. Consignees were also requested to confirm receipt of the letter through the Olympus web portal and forward the notification to other users who may have the affected products if product were further distributed.
Quantity in commerce: 808 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
Product codes and lots: 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, 44A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 4ZA, 51A.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1908-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1898-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1899-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1900-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1901-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1902-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1903-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1904-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1905-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1906-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1907-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1908-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22
Z-1909-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-22

Product code FEB

K201920Class IIEndoscope Reprocessor OER-EliteOlympus Medical Systems Corp. / cleared 2020-09-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)