Z-1610-2026Class II

Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443

Name: Z-1610-2026 Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443
Creator: Olympus Corporation of the Americas
Published: 2026-02-12
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2026-02-12 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443 on 2026-02-12. FDA classified it as Class II and gives the reason as "The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1610-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-12
Posted: 2026-03-20
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
Product code: ODC Endoscope Channel Accessory
Reason for recall: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
FDA root cause: Reprocessing Controls
Action: Olympus notified consignees on about 02/12/2026 via URGENT: MEDICAL DEVICE CORRECTION letter. Consignees were instructed to immediately cease reprocessing the MAJ-1443 and MAJ-1444 valves in an OER-Pro or OER-Elite and ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification and the full extent of the MAJ-1443 and MAJ-1444 reprocessing steps as detailed in the provided Instructions for Use (IFU). The updated IFU can also be accessed electronically through OlympusConnect.com. Additionally, consignees were instructed to replace any existing copies of the MAJ-1443/MAJ-1444 IFU with the updated IFU provided in this letter, identify and notify all customers if affected units were further distributed and complete and confirm receipt of the notification via the Olympus web portal.
Quantity in commerce: 47,383 units
Distribution: US Nationwide distribution.
Product codes and lots: Model Number: MAJ-1443. UDI-DI: 04953170355912. Catalog Number: N5363430. All Lot/Serial Numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1610-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1610-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20
Z-1611-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20
Z-1612-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20
Z-1613-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-20

Product code ODC

K250949Class IISuction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems Corporation / cleared 2025-07-16

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)