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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector

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 Class 2 Device Recall Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connectorsee related information
Date Initiated by FirmAugust 19, 2026
Date PostedSeptember 18, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3244-2026
Recall Event ID 99609
510(K)NumberK123319 
Product Classification Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
ProductOlympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.
Code Information Model Number: CD-B610LA. UDI-DI: 00821925039469. Lot Numbers: All unexpired lots.
FEI Number 2429304
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactAshley Troiani
484-5531029
Manufacturer Reason
for Recall		Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOlumpus 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.
Quantity in Commerce404 units
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KNS
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