Olympus Thunderbeat Hand Instruments May Have Damaged Probe Tips

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Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Olympus is recalling Thunderbeat 5mm,20cm hand instruments because their probe tips can break or detach. This could cause injury during medical procedures. Affected units have model TB-0520FCS and catalog number N5424110.

Why it’s dangerous

The probe tips can break or detach during use, potentially causing injury to the user or patient. This happens because the tips are designed to be single-use but may fail under normal operating conditions.

Who’s affected

Medical professionals using these instruments for procedures like surgery or dental work are most at risk. Patients using the instruments during procedures may also be affected.

How to tell if you have this one

Check for model TB-0520FCS and catalog number N5424110¿ on the instrument. All units produced are affected, including those with UDI numbers starting with 04953170383595 or 04953170383592.

Brand
Olympus
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Damage
Inspect the probe tips for cracks, breaks, or detachment. If damaged, stop using immediately.

✎ GovInfoNow

Questions people ask

Why is this recall happening?

The probe tips of the hand instruments can break or detach during use, which may cause injury.

What should I do if I have this product?

Check for damage to the probe tips. If damaged, stop using immediately. If the product is undamaged, contact Olympus for further instructions.

Are all units affected?

Yes, all units with model TB-0520FCS and catalog number N5424110¿ are affected.

Take action

Contact Olympus

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

✉️ Open in email

Subject: Recall Z-1002-2025 — Olympus Olympus

Hello,

I own a Olympus that is covered by recall Z-1002-2025 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-1002-2025 (November 25, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1002-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.

Olympus Corporation of the Americas recalls Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm,

Lower-risk recall