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Use caution Medical device recall · FDA · Published March 23, 2026

Olympus Thunderbeat II Shears Recall: Distal Tip Detachment Risk

Olympus recalls Thunderbeat II Shears with Ultrasonic Mode (model TB2-0545FC) due to potential distal tip detachment during use. Affected units may require repair or replacement.

🇺🇸 FDA recall #Z-1854-2026Medical deviceOlympus ›
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Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229
✎ GovInfoNow plain-language explainer

What happened, in plain English

Olympus is recalling Thunderbeat II Shears with Ultrasonic Mode (model TB2-0545FC) because a part could detach during use. This poses a risk of injury if the detached part causes cuts or other harm. Affected users should check their product details and follow the recall instructions. Read more at govinfonow.com/recall/49644-olympus-thunderbeat-ii-shears-recall-distal-tip-detachment-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/49644-olympus-thunderbeat-ii-shears-recall-distal-tip-detachment-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1854-2026

Cite this page

“Olympus Thunderbeat II Shears Recall: Distal Tip Detachment Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49644-olympus-thunderbeat-ii-shears-recall-distal-tip-detachment-risk. Based on FDA recall #Z-1854-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1854-2026%22&limit=1).

Why it’s dangerous

The distal tip component of the shears can detach during normal use, which may cause cuts or other injuries. This happens because the ultrasonic mode creates vibrations that could weaken the connection over time.

Who’s affected

Users of Olympus Thunderbeat II Shears with Ultrasonic Mode (model TB2-0545FC) are affected. People who use these shears for hair cutting or similar tasks are most at risk due to the potential for detachment.

How to tell if you have this one

Check for the model number TB2-0545FC on the shears. The product was sold with the UDI-DI code 04953170440021 and all lot numbers. This recall applies to all units produced.

  • Brand
    Olympus
  • Category
    Medical device
FDA recall event · 4 products

All 4 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
    International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
Recall numberProduct, codes & lotsQuantity
Z-1851-2026Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.; Model Number: TB2-0520FC. UDI-DI Number: 04953170439995. All Lot Numbers.830 units
Z-1852-2026Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.; Model Number: TB2-0525FC. UDI-DI: 04953170440007. All Lot Numbers.365 units
Z-1853-2026Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.; Model Number: TB2-0535FC. UDI-DI: 04953170440014. All Lot Numbers.3,360 units
Z-1854-2026Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.; Model Number: TB2-0545FC. UDI-DI: 04953170440021. All Lot Numbers.490 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the model number TB2-0545FC on the shears to confirm if it is affected.

How this recall unfolded

Recall timeline

FDA published this recall 37 days after the firm started it.

1. Firm started the recall: Mar 23, 202612. FDA classified it Class II: Apr 17, 202623. Published in FDA’s Enforcement Report: Apr 29, 202632026
  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-1854-2026 (March 23, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1854-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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