The Recall Desk
SevereFDA (Devices)·Z-3244-2026·Announced 2026-09-30

Olympus BiCOAG Hemostasis Probe Recall Due to Ceramic Tip Detachment Risk

Olympus is recalling 404 BiCOAG Hemostasis Probes because the ceramic tip may detach due to insufficient adhesive.

What this means for you

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe (4). The potential for a component to detach during use represents a significant risk of injury.

Plain-English summary

Olympus Corporation of the Americas is recalling 404 units of the Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector, Model/Catalog Number CD-B610LA. The recall is due to a manufacturing defect where the designated amount of adhesive was not applied, creating a potential for the ceramic tip to detach.

The affected products were distributed worldwide, including the United States, Canada, Latin America, Singapore, Hong Kong, and the European Union. The recall covers all unexpired lots of the product.

Healthcare providers and facilities should stop using the affected probes and contact Olympus for further instructions on return or replacement.

The recalled product

Product
Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Endoscopy / Hemostasis
Hazard
Affected units
404

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Olympus Corporation of the Americas

See all →

Same hazard · component detachment

See all →