Olympus Thunderbeat Hand Instruments Recalled for Breaking Probe Tips

Agency Publication Date: January 21, 2025

Summary

Olympus Corporation of the Americas is recalling approximately 886,628 Thunderbeat Front-Actuated Grip Type S Hand Instruments due to reports of probe tips being damaged or breaking during use. This defect includes pad damage and detachment, which can occur while the single-use sterile instruments are used in surgical procedures. While no injuries have been reported in the provided data, the recall covers 11 different product versions sold nationwide and internationally.

Risk

If the probe tip of a hand instrument breaks or a pad detaches during surgery, it could lead to unintended patient injury or leave foreign material inside the patient's body. The breakdown of these components during use may also disrupt critical surgical steps.

What You Should Do

This recall affects Olympus Thunderbeat Front-Actuated Grip Type S Hand Instruments in 5 mm diameters and lengths of 20 cm, 35 cm, and 45 cm.
Check your device packaging or inventory for catalog numbers R5000687, R5000688, N5424030, N5423730, N5423630, N5423330, N5423430, N5423510, N5423930, N5424110, or N5423810. See the Affected Products section below for the full list of affected codes.
Stop using the recalled hand instruments immediately and remove them from clinical use.
Contact Olympus Corporation of the Americas or your authorized medical distributor to arrange for the return, replacement, or correction of the recalled devices.
Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional information regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S

Variants: 5 mm, 35 cm

Model / REF:

TB-0535FCS

Lot Numbers:

All

UDI:

04953170409677

04953170383540

Catalog Number: R5000687; Recall #: Z-0993-2025

Product: Thunderbeat Front-Actuated Grip Type S (45 cm)

Variants: 5 mm, 45 cm

Model / REF:

TB-0545FCS

Lot Numbers:

All

UDI:

04953170409684

04953170383519

Catalog Number: R5000688; Recall #: Z-0994-2025

Product: THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S

Variants: 5 mm, 20 cm

Model / REF:

TB-0520FCS

Lot Numbers:

All

UDI:

04953170383588

04953170383585

Catalog Number: N5424030; Recall #: Z-0995-2025

Product: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S

Variants: 5 mm, 35 cm

Model / REF:

TB-0535FCS

Lot Numbers:

All

UDI:

04953170383557

04953170383554

Catalog Number: N5423730; Recall #: Z-0996-2025

Product: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S

Variants: 5 mm, 35 cm

Model / REF:

TB-0535FCS

Lot Numbers:

All

UDI:

04953170383540

04953170383547

Catalog Number: N5423630; Recall #: Z-0997-2025

Product: THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S

Variants: 5 mm, 45 cm

Model / REF:

TB-0545FCS

Lot Numbers:

All

UDI:

04953170383519

04953170383516

Catalog Number: N5423330; Recall #: Z-0998-2025

Product: THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S

Variants: 5 mm, 45 cm

Model / REF:

TB-0545FCS

Lot Numbers:

All

UDI:

04953170383526

04953170383523

Catalog Number: N5423430; Recall #: Z-0999-2025

Product: THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S

Variants: 5 mm, 45 cm

Model / REF:

TB-0545FCS

Lot Numbers:

All

UDI:

04953170383533

04953170383530

Catalog Number: N5423510; Recall #: Z-1000-2025

Product: THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S

Variants: 5 mm, 20 cm

Model / REF:

TB-0520FCS

Lot Numbers:

All

UDI:

04953170383571

04953170383578

Catalog Number: N5423930; Recall #: Z-1001-2025

Product: THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S

Variants: 5 mm, 20 cm

Model / REF:

TB-0520FCS

Lot Numbers:

All

UDI:

04953170383595

04953170383592

Catalog Number: N5424110; Recall #: Z-1002-2025

Product: Thunderbeat, 5MM, 35CM, Front-actuated Grip Type S

Variants: 5 mm, 35 cm

Model / REF:

TB-0535FCS

Lot Numbers:

All

UDI:

04953170383564

04953170383561

Catalog Number: N5423810; Recall #: Z-1003-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95950

Status: Active

Manufacturer: Olympus Corporation of the Americas

Sold By: Authorized Medical Distributors; Hospital Supply Chains

Manufactured In: United States

Units Affected: 11 products (495,865 units (96,253 US, 399,612 OUS); 34,325 units (13267 US, 21058 OUS); 36,712 units (OUS Only); 128,608 units (OUS ONLY); 54,500 units (OUS ONLY); 9,200 units (OUS ONLY); 4,055 units (OUS ONLY); 112 units (OUS ONLY); 84,570 units (4489 US, 80081 OUS); 11,329 units (OUS ONLY); 27,352 units (OUS ONLY))

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 · 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.

Summary

What You Should Do

This recall affects Olympus Thunderbeat Front-Actuated Grip Type S Hand Instruments in 5 mm diameters and lengths of 20 cm, 35 cm, and 45 cm.

Check your device packaging or inventory for catalog numbers R5000687, R5000688, N5424030, N5423730, N5423630, N5423330, N5423430, N5423510, N5423930, N5424110, or N5423810. See the Affected Products section below for the full list of affected codes.

Stop using the recalled hand instruments immediately and remove them from clinical use.

Contact Olympus Corporation of the Americas or your authorized medical distributor to arrange for the return, replacement, or correction of the recalled devices.

Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional information regarding this recall.

Affected Products

Product: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S

Variants: 5 mm, 35 cm

Model / REF:

TB-0535FCS

Lot Numbers:

All

UDI:

04953170409677

04953170383540

Catalog Number: R5000687; Recall #: Z-0993-2025

Product: Thunderbeat Front-Actuated Grip Type S (45 cm)

Variants: 5 mm, 45 cm

Model / REF:

TB-0545FCS

Lot Numbers:

All

UDI:

04953170409684

04953170383519

Catalog Number: R5000688; Recall #: Z-0994-2025

Product: THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S

Variants: 5 mm, 20 cm

Model / REF:

TB-0520FCS

Lot Numbers:

All

UDI:

04953170383588

04953170383585

Catalog Number: N5424030; Recall #: Z-0995-2025

Product: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S

Variants: 5 mm, 35 cm

Model / REF:

TB-0535FCS

Lot Numbers:

All

UDI:

04953170383557

04953170383554

Catalog Number: N5423730; Recall #: Z-0996-2025

Product: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S

Variants: 5 mm, 35 cm

Model / REF:

TB-0535FCS

Lot Numbers:

All

UDI:

04953170383540

04953170383547

Catalog Number: N5423630; Recall #: Z-0997-2025

Product: THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S

Variants: 5 mm, 45 cm

Model / REF:

TB-0545FCS

Lot Numbers:

All

UDI:

04953170383519

04953170383516

Catalog Number: N5423330; Recall #: Z-0998-2025

Product: THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S

Variants: 5 mm, 45 cm

Model / REF:

TB-0545FCS

Lot Numbers:

All

UDI:

04953170383526

04953170383523

Catalog Number: N5423430; Recall #: Z-0999-2025

Product: THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S

Variants: 5 mm, 45 cm

Model / REF:

TB-0545FCS

Lot Numbers:

All

UDI:

04953170383533

04953170383530

Catalog Number: N5423510; Recall #: Z-1000-2025

Product: THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S

Variants: 5 mm, 20 cm

Model / REF:

TB-0520FCS

Lot Numbers:

All

UDI:

04953170383571

04953170383578

Catalog Number: N5423930; Recall #: Z-1001-2025

Product: THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S

Variants: 5 mm, 20 cm

Model / REF:

TB-0520FCS

Lot Numbers:

All

UDI:

04953170383595

04953170383592

Catalog Number: N5424110; Recall #: Z-1002-2025

Product: Thunderbeat, 5MM, 35CM, Front-actuated Grip Type S

Variants: 5 mm, 35 cm

Model / REF:

TB-0535FCS

Lot Numbers:

All

UDI:

04953170383564

04953170383561

Catalog Number: N5423810; Recall #: Z-1003-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95950

Status: Active

Manufacturer: Olympus Corporation of the Americas

Sold By: Authorized Medical Distributors; Hospital Supply Chains

Manufactured In: United States

Distributed To: Nationwide