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

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

✎ GovInfoNow plain-language explainer

What happened, in plain English

Olympus is recalling Thunderbeat 5mm hand instruments that may have damaged or broken probe tips, causing pad detachment. This could lead to improper function during surgery. Affected units were sold with specific generators and have model numbers starting with TB-0545FCS.

Why it’s dangerous

The probe tips on these instruments can become damaged or break, leading to pad detachment. This may cause improper function during surgical procedures if the instrument is used without the probe tip being securely attached.

Who’s affected

Surgical staff using Olympus Thunderbeat hand instruments with USG-400 or WSG-400 generators. Most at risk are medical professionals handling these instruments during procedures.

How to tell if you have this one

Check for model number TB-0545FCS on the instrument. Affected units were sold with USG-400 or WSG-400 generators and have catalog number N5423430.

Brand
Olympus
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using Immediately
Discontinue use of the instrument if you have the model number TB-0545FCS.

✎ GovInfoNow

Questions people ask

What is the hazard with these instruments?

The probe tips can become damaged or broken, causing pad detachment which may lead to improper function during surgery.

What should I do if I have this instrument?

Stop using it immediately and contact Olympus for further instructions.

Which generators are affected?

The instruments were sold with USG-400 or WSG-400 generators.

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-0999-2025 — Olympus Olympus

Hello,

I own a Olympus that is covered by recall Z-0999-2025 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-0999-2025 (November 25, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0999-2025 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,45

Lower-risk recall