Class IIDeviceOngoing

Olympus Corporation of the Americas

Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.

Reason for recall

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

Details

Recall number: Z-3245-2026
Event ID: 99609
Recall initiated: Aug 19, 2026
Classified: Sep 18, 2026
Reported: Sep 30, 2026
Quantity: 105 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Center Valley, PA, United States
Lot / code info: Model Number: CD-B612LA. UDI-DI: 00821925039476. Lot Number: All unexpired lots.