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Unrated Medical device recall · FDA · Published October 22, 2025

Olympus Thunderbeat 5mm 45cm Recall: Safety Concerns

Olympus recalls Thunderbeat 5mm 45cm models due to safety concerns. Learn about affected units and what to do.

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

🇺🇸 FDA recall #Z-1371-2026Medical 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 their Thunderbeat 5mm, 45cm, Front-Actuated Grip Type S devices because of continued reports of adverse events. This recall affects all units with the specified model numbers and UDI codes. Read more at govinfonow.com/recall/51024-olympus-thunderbeat-5mm-45cm-recall-safety-concerns.

Source Summary by GovInfoNow · govinfonow.com/recall/51024-olympus-thunderbeat-5mm-45cm-recall-safety-concerns · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1371-2026

Cite this page

“Olympus Thunderbeat 5mm 45cm Recall: Safety Concerns.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51024-olympus-thunderbeat-5mm-45cm-recall-safety-concerns. Based on FDA recall #Z-1371-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1371-2026%22&limit=1).

Olympus Corporation of the Americas is recalling its Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S devices due to continued reports of adverse events, the FDA said on Oct. 22, 2025.

How to tell if you have it

  • Brand: Olympus
  • Product: Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
  • Model No.: TB-0545FCS
  • UDI: 04953170383533, 04953170383526, 04953170409684, 04953170383519
  • Lots: All Lots
  • Quantity: 9,542 units

The hazard

The firm is initiating a removal due to continued reports of adverse events.

Context

GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since Aug. 18, 2017. Other recent recalls by the brand include the Olympus Tripp-Lite P580-025 DisplayPort Cable (Aug. 27, 2026), the Olympus M3 Gold Autoclavable Foroblique Telescope (Aug. 24, 2026), and the BiCOAG Hemostasis Probe (Aug. 19, 2026). Other recent recalls of similar products include the Olympus OER-Pro (Oct. 31, 2025), the Olympus OER-Elite (Oct. 31, 2025), and the Olympus OER-Mini (Oct. 31, 2025).

How to tell if you have this one

Check for the model number TB-0545FCS or UDI codes 04953170383533, 04953170383526, 04953170409684, 04953170383519 on the product. All lots of this device are included in the recall.

  • Brand
    Olympus
  • Category
    Medical device
FDA recall event · 12 products

All 12 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
    Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
Recall numberProduct, codes & lotsQuantity
Z-1371-2026Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S; Model No. TB-0545FCS; UDI: 04953170383533, 04953170383526, 04953170409684, 04953170383519; All Lots.9,542 units
Z-1372-2026Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S; Model No. TB-0535FCS; UDI: 04953170383564, 04953170383557, 04953170409677, 04953170383540; All Lots.88,268 units
Z-1373-2026Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S; Model No. TB-0520FCS; UDI: 04953170383571, 0495317083595, 04953170383588; All Lots.4,181 units
Z-1374-2026Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip; Model No. TB-0545FC; UDI: 04953170337543; All Lots.0 units
Z-1375-2026Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip; Model No. TB-0535FC; UDI: 04953170337574, 04953170464959; All Lots.0 units
Z-1376-2026Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip; Lot Code: Model: TB-0520FC; UDI: 04953170370519, 04953170370502; All Lots.0 units
Z-1377-2026Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip; Model No. TB-0545PC; UDI: 04953170308635; All Lots.30 units
Z-1378-2026Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip; Model No. TB-0535PC; UDI: 04953170308659; All Lots.3,381 units
Z-1379-2026Olympus Thunderbeat, 5 mm, 45 cm Inline Grip; Model No. TB-0545IC; UDI: 04953170308673; All Lots.30 units
Z-1380-2026Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip; Model No. TB-0535IC; UDI: 04953170464973; All Lots.52 units
Z-1381-2026Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip; Model No. TB-0520IC; UDI: 04953170308581, 04953170608710; All Lots.140 units
Z-1382-2026Olympus Thunderbeat 5 mm, 10 cm, Inline Grip; Model No. TB-0510IC; UDI: 04953170308734; All Units.1,538 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the model number TB-0545FCS or UDI codes listed in the recall notice to confirm if your device is affected.

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: “Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.” 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 4 months after the firm started it.

1. Firm started the recall: Oct 22, 202512. FDA classified it Class II: Feb 17, 202623. Published in FDA’s Enforcement Report: Feb 25, 2026320252026
  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-1371-2026 (October 22, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1371-2026 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