Olympus Corporation Of The Americas recalls Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. Th…

Potential for rubber fragment detachment during use.

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.

• FDA enforcement recordOfficial FDA database entry for Z-1488-2026
• FDA 510(k) clearance · K061313The device's official FDA premarket clearance record
• FDA device classification · EOQOfficial FDA classification for this device type
• CFR regulation · 21 CFR 874.4680The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Olympus Corporation of the AmericasSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.