CLASS II ONGOING Device recall · Reported 25 Feb 2026 · FDA Enforcement Report

Olympus Thunderbeat, Front-Actuated Grip recalled

Olympus Corporation of the Americas is recalling Olympus Thunderbeat, Front-Actuated Grip, distributed nationwide in the US. The recall was initiated on 22 Oct 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel No. TB-0535FC; UDI: 04953170337574, 04953170464959; All Lots.
Quantity recalled0 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-1375-2026
FDA event ID
98188
Recalling firm
Olympus Corporation of the Americas, Center Valley, PA
Classification
Class II
Status
Ongoing
Recall initiated
22 Oct 2025
FDA classified
17 Feb 2026
Reported
25 Feb 2026
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

22 Oct 2025Recall initiated by company
17 Feb 2026Classified by FDA+118 days
25 Feb 2026Published in enforcement report+8 days

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

Reason for recall

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

Product as listed by the FDA

Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.

Nationwide

Questions about this recall

Is Olympus Thunderbeat, Front-Actuated Grip recalled?

Yes. Olympus Corporation of the Americas recalled Olympus Thunderbeat, Front-Actuated Grip on 22 Oct 2025. The recall is Class II and its status is Ongoing. Recall number Z-1375-2026.

Why was it recalled?

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

Which lots are affected?

Model No. TB-0535FC; UDI: 04953170337574, 04953170464959; All Lots.

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.

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

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