Device recall

Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.

FDA recall source

Recall number

Z-3247-2026

Event id

99609

Status

Ongoing

FDA classification

Class II

Recalling firm

Olympus Corporation of the Americas

Report date

Sep 30, 2026

Posted

Sep 18, 2026

Initiated

Aug 19, 2026

Center classification date

Sep 18, 2026

Product code

KNS

Device type

Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Reason

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

Root cause

Nonconforming Material/Component

Quantity

816 units

Code info

Lot Code: Model: CD-B622LA. UDI-DI: 00821925039452. Lot Numbers: All unexpired lots

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.

Voluntary or mandated

Voluntary: Firm initiated

Related 510(k)s

K123319

Location

Center Valley, PA, United States