FDA DevicesClass II
Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
Published: February 25, 2026Recall ID: Z-1378-2026Category: devicesCountry: US
Reason for Recall / Hazard
Firm is initiating a removal due to continued reports of adverse events.
Product Description & Identification
Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
Additional Source Details
| Field | Value |
|---|---|
| City | Center Valley |
| State | PA |
| Event id | 98188 |
| Address 1 | 3500 Corporate Pkwy |
| Code info | Model No. TB-0535PC; UDI: 04953170308659; All Lots. |
| Postal code | 18034-8229 |
| Report date | 20260225 |
| Product type | Devices |
| Product quantity | 3,381 units |
| Reason for recall | Firm is initiating a removal due to continued reports of adverse events. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251022 |
| Initial firm notification | Letter |
| Center classification date | 20260217 |
Overview
- Recalling FirmOlympus Corporation of the Americas
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.