Olympus Thunderbeat Hand Instruments: Probe Tips May Break

Take action

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 5mm, 35cm hand instruments because their probe tips can break, causing pad damage or detachment. This could lead to improper use during medical procedures. If you own this instrument, stop using it immediately.

Why it’s dangerous

The probe tips of these hand instruments can become damaged or break during use, leading to pad detachment. This could cause the instrument to malfunction during medical procedures, potentially affecting the procedure's safety and effectiveness.

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 the model number TB-0535FCS on the instrument. The catalog number N5423630 and UDI numbers 04953170383540 or 04953170383547 are also indicators of the recalled product.

Brand
Olympus
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using It Now
Immediately stop using the Thunderbeat 5mm, 35cm hand instrument if you have it.

✎ GovInfoNow

Questions people ask

What is the model number of the recalled instruments?

The model number is TB-0535FCS.

What catalog number identifies the recalled product?

The catalog number is N5423630.

Do I need to return the instrument?

The recall record does not specify a return process.

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-0997-2025 — Olympus Olympus

Hello,

I own a Olympus that is covered by recall Z-0997-2025 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.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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-0997-2025 (November 25, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0997-2025 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