Olympus Thunderbeat 5 mm — Class II medical device recall Z-1382-2026
Ongoing recall by Olympus Corporation of the Americas, reported 2026-02-25, distributed nationwide. Firm is initiating a removal due to continued reports of adverse events.
| Recall number | Z-1382-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2025-10-22 |
| Classified | 2026-02-17 |
| Reported by FDA | 2026-02-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, DE, JP, MX |
| Quantity | 1,538 units |
| UPC / GTIN / UDI-DI | 04953170308734 |
| Model numbers | TB-0510IC |
Product
Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
Reason for recall
Firm is initiating a removal due to continued reports of adverse events.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1382-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.