Z-1489-2026Class II

Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been...

Name: Z-1489-2026 Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been...
Creator: Olympus Corporation of the Americas
Published: 2026-01-29
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2026-01-29 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port... on 2026-01-29. FDA classified it as Class II and gives the reason as "Potential for rubber fragment detachment during use". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1489-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-29
Posted: 2026-03-03
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.
Product code: EOQ Bronchoscope (Flexible Or Rigid)
Reason for recall: Potential for rubber fragment detachment during use.
FDA root cause: Under Investigation by firm
Action: Olympus notified consignees on about 01/29/2026 via letter titled URGENT: FIELD SAFETY NOTICE. Consignees were instructed to carefully read the content of the notification, ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification, and that they may continue using the devices as per the notification and instructions for use. Olympus is highlighting the importance of strictly adhering to the Inspection of the Biopsy Valve and Inserting and Withdrawing the Endo-therapy accessories sections in the IFU related to the detachment of fragment from the slit part of rubber. Consignees were requested to acknowledge receipt of the notification via their portal and if product has been further distributed to notify those consignees.
Quantity in commerce: 1,276 boxes (20 units per box)
Distribution: US Nationwide distribution.
Product codes and lots: Model/Catalog Number: MAJ-1218. UDI-DI: 14953170154291. All Lot Numbers. 20 units per box.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1489-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1488-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-11	2026-03-03
Z-1489-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-11	2026-03-03

Product code EOQ

K061313Class IIEvis Exera 180 SystemOlympus Medical Systems Corporation / cleared 2006-08-31

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)