Class II — Olympus Corporation of the Americas
| Recalling firm | Olympus Corporation of the Americas |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. |
| Product | Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA. |
| Quantity | 105 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU. |
| Initiated | 2026-08-19 |
| Classified | 2026-09-18 |
| Recall number | Z-3245-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Olympus Corporation of the Americas (Z-3245-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99609/
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