—#218000

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.

FDA product code: EOQ — Bronchoscope (Flexible Or Rigid)
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K061313
Affected lot / code info: Model/Catalog Number: MAJ-1218. UDI-DI: 14953170154291. All Lot Numbers. 20 units per box.

Why it was recalled

Potential for rubber fragment detachment during use.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2026-01-29
Posted by FDA: 2026-03-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #218000. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.