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, 35cm hand instruments because their probe tips can break or detach, potentially causing injury during use. This affects instruments sold with specific surgical generators.

Why it’s dangerous

The probe tips can become damaged or break during use, leading to pad detachment. This could cause injury if the instrument slips or malfunctions during surgery.

Who’s affected

Surgical professionals using Olympus Thunderbeat instruments with USG-400 or WSG-400 generators 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 N5423730 on the instrument. These units were sold with USG-400 or WSG-400 surgical generators.

Brand
Olympus
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Instrument Model
Look for model number TB-0535FCS and catalog number N5423730 on the instrument.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The probe tips of the hand instruments can become damaged or broken, including pad damage and detachment.

What should I do if I have this product?

The recall record does not specify a remedy, so contact Olympus directly for guidance.

Which surgical generators are affected?

These 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-0996-2025 — Olympus Olympus

Hello,

I own a Olympus that is covered by recall Z-0996-2025 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-0996-2025 (November 25, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0996-2025 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,35 cm,

Lower-risk recall