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Z-3245-2026Class II

Olympus Corporation of the Americas

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Olympus Corporation of the Americas
Product type
Device
Status
Ongoing
Report date
2026-09-30
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.
Firm state
PA
Product quantity
105 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

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

Product description

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

Code / lot info

Model Number: CD-B612LA. UDI-DI: 00821925039476. Lot Number: All unexpired lots.

Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →