Official recall notice

FDA DeviceClass IINotable

Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Recall (Sep 2026)

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

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

Verify with the official notice →
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