Olympus Thunderbeat Hand Instruments: Probe Tips May Break

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Contact the company & request your remedy

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

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Olympus is recalling Thunderbeat hand instruments that may have broken probe tips, causing pad damage or detachment. This could lead to instrument failure during use, potentially affecting medical procedures.

Why it’s dangerous

The probe tips on these hand instruments can become damaged or break during use, leading to pad damage or detachment. This may cause the instrument to malfunction or become unsafe during medical procedures.

Who’s affected

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

How to tell if you have this one

Check for model number TB-0535FCS and catalog number N5423810 on the instrument. These instruments were sold with all lots and are used with Olympus Ultrasonic or Electrosurgical Generators.

Brand
Olympus
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using It Now
If you have the recalled Thunderbeat hand instruments, stop using them immediately to prevent potential malfunction.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The probe tips of the hand instruments may be damaged or breaking, causing pad damage or detachment during use.

What should I do if I have this product?

Stop using the instrument immediately and contact Olympus for further instructions.

Are there any specific model numbers for this recall?

Yes, the model number is TB-0535FCS and the catalog number is N5423810.

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-1003-2025 — Olympus Olympus

Hello,

I own a Olympus that is covered by recall Z-1003-2025 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-1003-2025 (November 25, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1003-2025 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, 5MM, 35CM,

Lower-risk recall