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Ongoing FDAEvent 99609 (27 days ago)

Olympus BiCOAG Hemostasis Probe

The Olympus BiCOAG Hemostasis Probe may have a ceramic tip that can detach.

Moderate risk

Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.

FDA Class II recall · How risk is rated

What to do

What happened

Olympus Corporation of the Americas, based in Center Valley, Pennsylvania, began a recall on August 19, 2026, for four Olympus BiCOAG Hemostasis Probe models due to potential for detachment of ceramic tip caused by manufacturing without the designated amount of adhesive.

The affected products are the 7Fr Fixed Pin Connector, 10Fr Fixed Pin Connector, 7Fr Coaxial Connector, and 10Fr Coaxial Connector. The recall was added to the FDA's Enforcement Report and classified on September 18, 2026, with distribution worldwide, including the US Nationwide, Canada, Latin America, Singapore, Hong Kong, and the EU.

Summary by Recall Canary from the FDA notice.

More device defect recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

4 products

Match the UDI-DI and catalog code listed under your product.

  1. Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/

    UDI-DI
    • 00821925039452
    Catalog code
    • CD-B622LA.

  2. Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/

    UDI-DI
    • 00821925039476
    Catalog code
    • CD-B612LA.

  3. Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/

    UDI-DI
    • 00821925039483
    Catalog code
    • CD-B620LA.

  4. Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/

    UDI-DI
    • 00821925039469
    Catalog code
    • CD-B610LA.

Details

Company began the recall
Sold in

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

Event ID
99609
Recall numbers
Z-3244-2026 to Z-3247-2026
Company
Olympus Corporation of the AmericasCenter Valley, Pennsylvania
Hazard
Device defect
Recall type
Voluntary: Firm initiated
Customers told by
Letter

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

All recalls from Olympus Corporation of the Americas

Other device defect recalls

See all

Summary by Recall Canary, written with AI · summary updated Oct 2, 2026 · primary source: U.S. Food and Drug Administration