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Medical device recall · FDA · Published August 19, 2026

Olympus Corporation of the Americas recalls Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.

Olympus recalls BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector (CD-B622LA) due to potential ceramic tip detachment from improper adhesive application. All unexpired lots affected.

🇺🇸 FDA recall #Z-3247-2026Medical deviceOlympus ›
✎ GovInfoNow plain-language explainer

What happened, in plain English

Olympus is recalling its BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector (model CD-B622LA) because it may detach due to insufficient adhesive during manufacturing. This could lead to injury during medical procedures if the tip separates unexpectedly. Read more at govinfonow.com/recall/1292584-olymp-bicoag-hemostasis-probe-7fr-connector-recall-detachment-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/1292584-olymp-bicoag-hemostasis-probe-7fr-connector-recall-detachment-risk · Published October 6, 2026 · Updated October 6, 2026 · FDA enforcement record: FDA #Z-3247-2026

Cite this page

“Olymp: BiCOAG Hemostasis Probe 7Fr Connector Recall - Detachment Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/1292584-olymp-bicoag-hemostasis-probe-7fr-connector-recall-detachment-risk. Based on FDA recall #Z-3247-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3247-2026%22&limit=1).

Why it’s dangerous

The ceramic tip may detach because the connector was manufactured without the correct amount of adhesive. This could happen during use, potentially causing injury if the detached tip strikes a patient or medical staff.

Who’s affected

Healthcare professionals using the probe for hemostasis procedures are most at risk. Patients receiving procedures with this device could be affected if the tip detaches.

How to tell if you have this one

Check for the model number CD-B622LA on the connector. All unexpired lots are affected, so look for any lot numbers listed in the recall notice.

  • Brand
    Olympus
  • Category
    Medical device
FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.
Recall numberProduct, codes & lotsQuantity
Z-3244-2026Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.; Model Number: CD-B610LA. UDI-DI: 00821925039469. Lot Numbers: All unexpired lots.404 units
Z-3245-2026Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.; Model Number: CD-B612LA. UDI-DI: 00821925039476. Lot Number: All unexpired lots.105 units
Z-3246-2026Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.; Lot Code: Model: CD-B620LA. UDI-DI: 00821925039483. Lot Numbers: All unexpired lots.2,142 units
Z-3247-2026Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.; Lot Code: Model: CD-B622LA. UDI-DI: 00821925039452. Lot Numbers: All unexpired lots816 units
Based on the official FDA remedy

What to do — step by step

  1. Check for Detachment Risk

    Inspect the connector for signs of improper adhesive application, such as cracks or loose fittings.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall states the connector may detach due to manufacturing issues, so it is not safe to use as is. Check for detachment risk before use.

What should I do if I have this product?

The recall does not specify a remedy, so contact Olympus directly for guidance on safe handling or disposal.

Are there any specific lot numbers affected?

The recall states all unexpired lots are affected, so no specific lot numbers are listed.

Take action

Contact Olympus

We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.

Subject: Recall Z-3247-2026 — Olympus Olympus

Hello,

I own a Olympus that is covered by recall Z-3247-2026 from Olympus.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-3247-2026 (August 19, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3247-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA