FDA Medical devices recall ·
Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip recall
- Recall number
- Z-1380-2026
- Date
- (initiated October 22, 2025)
- Company / brand
- Olympus Corporation of the Americas
3500 Corporate Pkwy, Center Valley, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 52 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip
Why was it recalled?
Firm is initiating a removal due to continued reports of adverse events.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No. TB-0535IC; UDI: 04953170464973; All Lots.
Distribution
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1380-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.