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Home › FDA recalls › Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector.
CLASS II · ModerateFDA

Olympus Corporation of the Americas recalls Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector.

📅 Aug 19, 2026 · 📍 Nationwide
Recalling company
Olympus Corporation of the Americas
Product
Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.
Reason
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Aug 19, 2026
Reported
Sep 30, 2026
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.
Status
Ongoing
Quantity
105 units
Lot / codes
Model Number: CD-B612LA. UDI-DI: 00821925039476. Lot Number: All unexpired lots.
Company location
Center Valley, PA
Recall type
Voluntary: Firm initiated
Recall number
Z-3245-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-3245-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.