Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA. recall (Olympus Corporation of the Americas)
Medical deviceClass IIOngoing
Summary: Olympus Corporation of the Americas is recalling Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.. Reason: Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
What is being recalled
Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.
Why
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.
How to tell if yours is affected
Lot Code: Model: CD-B620LA. UDI-DI: 00821925039483. Lot Numbers: All unexpired lots.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3246-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 19, 2026 |
| Reported | September 30, 2026 |
| Company | Olympus Corporation of the Americas |
| Company location | Center Valley, PA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 2,142 units |
More recalls from Olympus Corporation of the Americas · all medical device recalls · recalls from August 2026