Olympus Corporation Of The Americas recalls Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.

Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

Olumpus notified consignees on 08/19/2026 via "URGENT: MEDICAL DEVICE REMOVAL" letter. Consignees were informed of the reason for recall and hazard involved. Consignees were instructed to examine inventory for affected units, immediately cease use and quarantine them, arrange for their return, and confirm receipt of the recall notification through the portal. Consignees were also instructed to notify customers if product has been further distributed.

• FDA enforcement recordOfficial FDA database entry for Z-3244-2026
• FDA 510(k) clearance · K123319The device's official FDA premarket clearance record
• FDA device classification · KNSOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.4300The 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.