CLASS II ONGOING Device recall · Reported 25 Feb 2026 · FDA Enforcement Report
Olympus Thunderbeat, Inline Grip recalled by Olympus Corporation of the
Olympus Corporation of the Americas is recalling Olympus Thunderbeat, Inline 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
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-1382-2026
- 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
- Device type
- Other Medical Devices
Timeline
| 22 Oct 2025 | Recall initiated by company | |
| 17 Feb 2026 | Classified by FDA | +118 days |
| 25 Feb 2026 | Published 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, 10 cm, Inline Grip
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
Questions about this recall
Why was it recalled?
Firm is initiating a removal due to continued reports of adverse events.
Which lots are affected?
Model No. TB-0510IC; UDI: 04953170308734; All Units.
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 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
11 other products · FDA event 98188This product is part of a recall event; the main page for the event is Olympus Thunderbeat, Front-Actuated Grip Type S recalled.
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