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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Olympus Thunderbeat Surgical Devices Recalled for Adverse Events

Agency Publication Date: February 17, 2026
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Summary

Olympus Corporation of the Americas is recalling approximately 107,162 Thunderbeat surgical instruments due to a continued number of reported adverse events. These devices are used in surgical procedures to cut tissue and seal blood vessels using a combination of ultrasonic and advanced bipolar energy. While the specific nature of the adverse events was not detailed in the notice, the firm is initiating a removal to ensure patient safety.

Risk

The continued reports of adverse events suggest a potential failure in device performance or safety during surgical procedures, which could lead to surgical complications or injury to patients. No specific injury counts were provided in this update, but the recall is classified as a medium risk removal.

What You Should Do

  1. Identify if your facility has any of the recalled Olympus Thunderbeat devices by checking the model and UDI numbers on the product packaging or device labels. See the Affected Products section below for the full list of affected codes.
  2. Stop using the recalled devices immediately and quarantine any remaining stock to prevent further clinical use.
  3. Contact Olympus Corporation of the Americas or your authorized distributor to arrange for the return, replacement, or correction of the affected units.
  4. If you have questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
Variants: 5 mm, 45 cm, Front-Actuated Grip Type S
Model / REF:
TB-0545FCS
Lot Numbers:
All Lots
UDI:
04953170383533
04953170383526
04953170409684
04953170383519

9,542 units affected.

Product: Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
Variants: 5 mm, 35 cm, Front-Actuated Grip Type S
Model / REF:
TB-0535FCS
Lot Numbers:
All Lots
UDI:
04953170383564
04953170383557
04953170409677
04953170383540

88,268 units affected.

Product: Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S
Variants: 5 mm, 20 cm, Front-Actuated Grip Type S
Model / REF:
TB-0520FCS
Lot Numbers:
All Lots
UDI:
04953170383571
0495317083595
04953170383588

4,181 units affected.

Product: Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip
Variants: 5 mm, 45 cm, Front-Actuated Grip
Model / REF:
TB-0545FC
Lot Numbers:
All Lots
UDI:
04953170337543

0 units affected in this specific distribution lot.

Product: Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
Variants: 5 mm, 35 cm, Front-Actuated Grip
Model / REF:
TB-0535FC
Lot Numbers:
All Lots
UDI:
04953170337574
04953170464959

0 units affected in this specific distribution lot.

Product: Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
Variants: 5 mm, 20 cm, Front-Actuated Grip
Model / REF:
TB-0520FC
Lot Numbers:
All Lots
UDI:
04953170370519
04953170370502

0 units affected in this specific distribution lot.

Product: Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip
Variants: 5 mm, 45 cm, Pistol Grip
Model / REF:
TB-0545PC
Lot Numbers:
All Lots
UDI:
04953170308635

30 units affected.

Product: Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
Variants: 5 mm, 35 cm, Pistol Grip
Model / REF:
TB-0535PC
Lot Numbers:
All Lots
UDI:
04953170308659

3,381 units affected.

Product: Olympus Thunderbeat, 5 mm, 45 cm Inline Grip
Variants: 5 mm, 45 cm, Inline Grip
Model / REF:
TB-0545IC
Lot Numbers:
All Lots
UDI:
04953170308673

30 units affected.

Product: Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip
Variants: 5 mm, 35 cm, Inline Grip
Model / REF:
TB-0535IC
Lot Numbers:
All Lots
UDI:
04953170464973

52 units affected.

Product: Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip
Variants: 5 mm, 20 cm, Inline Grip
Model / REF:
TB-0520IC
Lot Numbers:
All Lots
UDI:
04953170308581
04953170608710

140 units affected.

Product: Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
Variants: 5 mm, 10 cm, Inline Grip
Model / REF:
TB-0510IC
Lot Numbers:
All Units
UDI:
04953170308734

1,538 units affected.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98188
Status: Active
Manufacturer: Olympus Corporation of the Americas
Sold By: Hospital supply distributors; Medical device wholesalers; Direct sales from Olympus
Manufactured In: United States
Units Affected: 12 products (9,542 units; 88,268 units; 4,181 units; 0 units; 0 units; 0 units; 30 units; 3,381 units; 30 units; 52 units; 140 units; 1,538 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.