Olympus Corporation of the Americas: Olympus Thunderbeat, 5 mm, 45 cm Inline Grip
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Olympus Corporation of the Americas
- Product
- Olympus Thunderbeat, 5 mm, 45 cm Inline Grip
- Reason / hazard
- Firm is initiating a removal due to continued reports of adverse events.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
- Recall initiated
- 2025-10-22
- Code info
- Model No. TB-0545IC; UDI: 04953170308673; All Lots.
- Product quantity
- 30 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Center Valley
- State
- PA
- Country
- United States
- Event id
- 98188
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