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Open, Classified

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

FDA Recall Z-3244-2026 · Posted 2026-09-18

Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeKNS
Date Initiated2026-08-19
Product Quantity404 units

Reason for Recall

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

Firm Action

Olumpus notified consignees on 08/19/2026 via "URGENT: MEDICAL DEVICE REMOVAL" letter. Consignees were informed of the reason for recall and hazard involved. Consignees were instructed to examine inventory for affected units, immediately cease use and quarantine them, arrange for their return, and confirm receipt of the recall notification through the portal. Consignees were also instructed to notify customers if product has been further distributed.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123319GYRUS ACMI BICOAG HEMOSTASIS PROBEOlympus Surgical Technologies America · 2012-12-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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