OVERLOOKED

Recalls › Medicines & devices

Class IIOngoing

Olympus Corporation of the Americas recalls 4 products

Recall date · record updated Sep 30, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Olympus Corporation of the Americas
Reason
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99609…

Products (4)

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

    Codes/lots: Model Number: CD-B610LA. UDI-DI: 00821925039469. Lot Numbers: All unexpired lots.Quantity: 404 unitsRecall no. Z-3244-2026Class II

  2. Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.

    Codes/lots: Model Number: CD-B612LA. UDI-DI: 00821925039476. Lot Number: All unexpired lots.Quantity: 105 unitsRecall no. Z-3245-2026Class II

  3. Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.

    Codes/lots: Lot Code: Model: CD-B620LA. UDI-DI: 00821925039483. Lot Numbers: All unexpired lots.Quantity: 2,142 unitsRecall no. Z-3246-2026Class II

  4. Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.

    Codes/lots: Lot Code: Model: CD-B622LA. UDI-DI: 00821925039452. Lot Numbers: All unexpired lotsQuantity: 816 unitsRecall no. Z-3247-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

More Medicines & devices recalls