Official recall notice

FDA DeviceClass IINotable

Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Recall (Sep 2026)

Product: Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.

Recall date
2026-09-30
FDA class
Class II

Why it was recalled

Hazard

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

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Product description

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

Affected products

Model Number: CD-B610LA. UDI-DI: 00821925039469. Lot Numbers: All unexpired lots.

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