Class II U.S. Food and Drug Administration

Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/ recall: Potential for detachment of ceramic tip due to manufacturing without

Recall published 25 days ago

Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-3245-2026
Published
September 30, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Olympus Corporation of the Americas
Product type
Medical devices
Units affected
105 units
Distribution
Nationwide
Made in
United States
Lot / code info
Model Number: CD-B612LA. UDI-DI: 00821925039476. Lot Number: All unexpired lots.

Products covered by this recall

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

What to do about Device

Olympus Corporation of the Americas — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Olympus Corporation of the Americas — 3500 Corporate Pkwy, Center Valley, PA, 18034-8229

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Olympus Corporation of the Americas medical devices recalled?

Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Device enforcement record, and contact the company if you are unsure.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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