Ceramic Tip Detachment Risk Sparks Olympus BiCOAG Probe Recall in Canada

A ceramic tip that can come loose during use has prompted Health Canada to issue a recall notice for the BiCOAG Hemostasis Probe, a surgical device manufactured by Gyrus Acmi, Inc., an Olympus company. The recall, identified under number RA-82587, was announced on August 18, 2026, and affects four specific models of the probe used in general and plastic surgery procedures.

According to Olympus, the affected devices may have left the factory without the designated amount of adhesive applied to the rear of the device’s ceramic tip. That manufacturing gap raises the possibility that the tip could separate from the probe while it is being used on a patient, a scenario that carries obvious risks in a surgical setting.

Products Affected by This Recall

The recall covers four catalogue numbers of the BiCOAG Hemostasis Probe, sold under two connector types:

• BiCOAG Hemostasis Probe – Fixed Pin Connector, model CD-B622LA
• BiCOAG Hemostasis Probe – Fixed Pin Connector, model CD-B612LA
• BiCOAG Hemostasis Probe – Coaxial Connector, model CD-B610LA
• BiCOAG Hemostasis Probe – Coaxial Connector, model CD-B620LA

Health Canada’s notice states that more than ten lot or serial numbers are involved across these models, and that healthcare facilities holding the devices should contact the manufacturer directly to confirm whether their specific units are included.

What Triggered the Recall

The issue traces back to an assembly step in which adhesive is applied to secure the ceramic tip to the body of the probe. Olympus determined that some units did not receive the full amount of adhesive required at that joint. Over time, or during active use, that shortfall could allow the tip to detach from the device.

Because the BiCOAG Hemostasis Probe is used during surgical procedures to control bleeding through bipolar coagulation, a detached component poses a direct hazard inside the surgical field. Health Canada has classified the action as a Type II recall, a category reserved for situations where use of the product could cause temporary or medically reversible harm.

Who Is Affected?

This recall is directed at healthcare facilities and surgical staff who use the BiCOAG Hemostasis Probe rather than individual consumers. The product is distributed to hospitals and surgical centres, and the notice specifically lists ‘Healthcare’ as its intended audience. Gyrus Acmi, Inc. is based in Brooklyn Park, Minnesota, and markets the device across Canada through its Olympus surgical technologies division.

Health Canada has not indicated any confirmed patient injuries linked to the affected units at the time the notice was published, but the agency is asking facilities to act on the alert without delay given the nature of the defect.

What Consumers Need to Do Now

Health Canada and Olympus are advising anyone with access to the affected BiCOAG Hemostasis Probe models to stop using the devices immediately. Facilities should:

• Discontinue use of any BiCOAG Hemostasis Probe matching the listed catalogue numbers
• Check device documentation or contact Olympus/Gyrus Acmi to verify affected lot or serial numbers
• Set aside the affected units and arrange return to the manufacturer
• Contact Olympus directly for additional guidance or replacement device information

Facilities that require more detail on the recall or need help identifying whether their inventory is affected are directed to reach out to the manufacturer rather than relying solely on the model number alone, since the defect is tied to specific lots within each model line.

Official Statement

In its notice, Olympus stated that it ‘determined that the affected products may have been manufactured without the designated amount of adhesive to the rear of the device’s ceramic tip, which may result in detachment of the ceramic tip.’ The company added that ‘customers should immediately discontinue using the BiCOAG Hemostasis Probe products and contact Olympus to return the product.’

Health Canada published the alert as part of its ongoing monitoring of medical device safety and continues to track manufacturer-reported recalls affecting products sold in Canada. Anyone with concerns about a related device or an adverse event can report it directly to Health Canada through its health and safety concern reporting service.