BiCOAG recallZ-3244-2026 · Olympus Corporation of the Americas · initiated Aug 19, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-3244-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 19, 2026
- Posted by the FDA
- Sep 18, 2026
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 404 units
- Product code
- KNS
- FDA submissions
- K123319
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.
Product description
Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.
Code information (models, lots, serial numbers)
Model Number: CD-B610LA. UDI-DI: 00821925039469. Lot Numbers: All unexpired lots.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BiCOAG CD-B610LAGyrus ACMI, LLC · Unit, electrosurgical, endoscopic (with or without accessories)1 recall7 reports
Product lines
Other devices under the same FDA submission
3 devices cleared under K123319 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- BiCOAG CD-B622LAGyrus ACMI, LLC · Unit, electrosurgical, endoscopic (with or without accessories)2 recalls16 reports
- BiCOAG CD-B620LAGyrus ACMI, LLC · Unit, electrosurgical, endoscopic (with or without accessories)1 recall7 reports
- BiCOAG CD-B612LAGyrus ACMI, LLC · Unit, electrosurgical, endoscopic (with or without accessories)1 recall6 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99609).
- Z-3245-2026 · Open, ClassifiedOlympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.
- Z-3246-2026 · Open, ClassifiedOlympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.
- Z-3247-2026 · Open, ClassifiedOlympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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