Olympus Thunderbeat II Shears w/Ultrasonic Mode — Class II medical device recall Z-1854-2026
Ongoing recall by Olympus Corporation of the Americas, reported 2026-04-29. Potential for detachment of a distal tip component of the device during use.
| Recall number | Z-1854-2026 |
|---|---|
| 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 | 2026-03-23 |
| Classified | 2026-04-17 |
| Reported by FDA | 2026-04-29 |
| Countries outside the US | AU, HK, JP |
| Quantity | 490 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04953170440021 |
| Model numbers | TB2-0545FC |
Product
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
Reason for recall
Potential for detachment of a distal tip component of the device during use.
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-1854-2026. 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.