Z-3244-2026Class II

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

Name: Z-3244-2026 Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA
Creator: Olympus Corporation of the Americas
Published: 2026-08-19
License: https://open.fda.gov/license/

Olympus Corporation of the Americas / initiated 2026-08-19 / Open, Classified

FDA source

Recall record

Recall number: Z-3244-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-19
Posted: 2026-09-18
Recalling firm: Olympus Corporation of the Americas
Product: Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.
Product code: KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Reason for recall: Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 404 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.
Product codes and lots: Model Number: CD-B610LA. UDI-DI: 00821925039469. Lot Numbers: All unexpired lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3244-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3244-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18
Z-3245-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18
Z-3246-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18
Z-3247-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18

Product code KNS

K123319Class IIGyrus Acmi Bicoag Hemostasis ProbeOlympus Surgical Technologies America / cleared 2012-12-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-23. View this recall on fda.gov (opens on fda.gov)