Olympus Thunderbeat Hand Instruments: Probe Tips May Break

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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 Front-Actuated Grip Type S hand instruments because their probe tips can break, leading to pad damage or detachment. This could cause injury during medical procedures if the instrument malfunctions.

Why it’s dangerous

The probe tips on these hand instruments can become damaged or break during use, causing pad damage or detachment. This could lead to instrument malfunction during medical procedures, potentially causing injury.

Who’s affected

Medical professionals using Olympus Thunderbeat 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-0545FCS and catalog number R5000688 on the instrument. All units produced are affected, including those with unique identifiers starting with 04953170409684 or 04953170383519.

Brand
Olympus
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Instrument Details
Look for model number TB-0545FCS and catalog number R5000688 on the instrument.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The probe tips of the hand instruments can become damaged or break, causing pad damage or detachment during use.

What should I do if I have this product?

The recall does not specify a remedy, so check with Olympus for further instructions.

Are all units affected?

Yes, all units with model TB-0545FCS and catalog number R5000688 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-0994-2025 — Olympus Olympus

Hello,

I own a Olympus that is covered by recall Z-0994-2025 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-0994-2025 (November 25, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0994-2025 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 Front-Actuated

Lower-risk recall