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Lower risk Medical device recall · FDA · Published November 25, 2024

Olympus Thunderbeat Hand Instruments May Have Damaged Probe Tips

Olympus recalls Thunderbeat 5mm, 35cm hand instruments with damaged or broken probe tips that could cause pad detachment. Affected units sold with USG-400 or WSG-40:00 generators.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0996-2025Medical deviceOlympus ›
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Contact the company

Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/53390-olympus-thunderbeat-hand-instruments-may-have-damaged-probe-tips.

Source Summary by GovInfoNow · govinfonow.com/recall/53390-olympus-thunderbeat-hand-instruments-may-have-damaged-probe-tips · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0996-2025

Cite this page

“Olympus Thunderbeat Hand Instruments May Have Damaged Probe Tips.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53390-olympus-thunderbeat-hand-instruments-may-have-damaged-probe-tips. Based on FDA recall #Z-0996-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0996-2025%22&limit=1).

Olympus Corporation of the Americas is recalling THUNDERBEAT 5 mm,35 cm hand instruments due to damaged or broken probe tips, the FDA said on 2024-11-25.

How to tell if you have it

  • Brand: Olympus
  • Product Name: THUNDERBEAT 5 mm,35 cm
  • Model Number: TB-0535FCS
  • Catalog Number/Product Code: N5423730
  • Lots: All

The hazard

The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

Context

GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since 2017-08-18. Other recent recalls include an Olympus Tripp-Lite P580-025 DisplayPort Cable (2026-08-27), an Olympus M3 Gold Autoclavable Foroblique Telescope 30 (2026-08-24), and an Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector (2026-08-19). Other recent recalls of similar products include a Merit Medical Custom Procedure Kit Recall (2025-12-04).

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
FDA recall event · 11 products

All 11 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution and International: Algeria, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Nepale, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Utd.Arab Emir., Vietnam, Yemen.
Recall numberProduct, codes & lotsQuantity
Z-0993-2025Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: R5000687 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).; Model Number: TB-0535FCS; Catalog Number/Product Code: R5000687; UDI: 04953170409677 and 04953170383540; Lots: All495,865 units (96,253 US, 399,612 OUS)
Z-0994-2025Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: R5000688 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).; Model: TB-0545FCS; Catalog Number/Product Code: R5000688; UDI: 04953170409684, 04953170383519; Lots: All;34,325 units (13267 US, 21058 OUS)
Z-0995-2025Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5424030 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).; Model: TB-0520FCS; Catalog Number/Product Code: N5424030; UDI: 04953170383588, 04953170383585; Lots: All36,712 units (OUS Only)
Z-0996-2025Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N5423730 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).; Model: TB-0535FCS; Catalog Number/Product Code: N5423730; UDI: 04953170383557, 04953170383554; Lots: All128,608 units (OUS ONLY)
Z-0997-2025Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm ,Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N5423630 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).; Model: TB-0535FCS; Catalog Number/Product Code: N5423630; UDI: 04953170383540, 04953170383547; Lots: All54,500 units (OUS ONLY)
Z-0998-2025Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423330 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).; Model: TB-0545FCS; Catlog Number/Product Code: N5423330; UDI: 04953170383519, 04953170383516; Lots: All9,200 units (OUS ONLY)
Z-0999-2025Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423430 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).; Model: TB-0545FCS; Catalog Number/Product Code: N5423430; UDI: 04953170383526, 04953170383523; Lots: All4,055 units (OUS ONLY)
Z-1000-2025Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423510 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).; Model: TB-0545FCS; Catalog Number/Product Code: N5423510; UDI: 04953170383533, 04953170383530; Lots: All112 units (OUS ONLY)
Z-1001-2025Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5423930 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).; Model: TB-0520FCS; Catalog Number/Product Code: N5423930; UDI: 04953170383571, 04953170383578; Lots: All84,570 units (4489 US, 80081 OUS)
Z-1002-2025Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5424110¿ Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).; Model: TB-0520FCS; Catalog Number/Product Code: N5424110¿; UDI: 04953170383595, 04953170383592; Lots: All11,329 units (OUS ONLY)
Z-1003-2025Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat, 5MM, 35CM, Front-actuated Grip Type S¿ Model Number: TB-0535FCS Catalog Number/Product Code: N5423810 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).; Model: TB-0535FCS; Catalog Number/Product Code: N5423810; UDI: 04953170383564, 04953170383561; Lots: All27,352 units (OUS ONLY)
Based on the official FDA remedy

What to do — step by step

  1. Check Instrument Model

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

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution and International: Algeria, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Costa Rica,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Nov 25, 202412. FDA classified it Class II: Jan 21, 202523. Published in FDA’s Enforcement Report: Jan 29, 2025320242025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA