CLASS II ONGOING Device recall · Reported 29 Apr 2026 · FDA Enforcement Report

Olympus Thunderbeat II Shears w/Ultrasonic Mode recalled

Olympus Corporation of the Americas is recalling Olympus Thunderbeat II Shears w/Ultrasonic Mode. The recall was initiated on 23 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: TB2-0545FC. UDI-DI: 04953170440021. All Lot Numbers.

Quantity recalled490 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1854-2026
FDA event ID: 98550
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 23 Mar 2026
FDA classified: 17 Apr 2026
Reported: 29 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

23 Mar 2026	Recall initiated by company
17 Apr 2026	Classified by FDA	+25 days
29 Apr 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for detachment of a distal tip component of the device during use.

Product as listed by the FDA

Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.

Where it was distributed

International distribution in the countries of Australia, Japan, Hong Kong, and Europe.

Questions about this recall

Why was it recalled?

Potential for detachment of a distal tip component of the device during use.

Which lots are affected?

Model Number: TB2-0545FC. UDI-DI: 04953170440021. All Lot Numbers.

Where was it sold?

International distribution in the countries of Australia, Japan, Hong Kong, and Europe.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 98550

Reported	Class	Recall	Company	Reason	Where
29 Apr 2026	CLASS II	Olympus Thunderbeat II Shears w/Ultrasonic Mode recalled	Olympus Corporation of the Americas	Other	PA
29 Apr 2026	CLASS II	Olympus Thunderbeat II Shears w/Ultrasonic Mode recalled	Olympus Corporation of the Americas	Other	PA
29 Apr 2026	CLASS II	Olympus Thunderbeat II Shears w/Ultrasonic Mode recalled	Olympus Corporation of the Americas	Other	PA

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