Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand… — Class II medical device recall Z-1000-2025
Ongoing recall by Olympus Corporation of the Americas, reported 2025-01-29, distributed nationwide. The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
| Recall number | Z-1000-2025 |
|---|---|
| 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 | 2024-11-25 |
| Classified | 2025-01-21 |
| Reported by FDA | 2025-01-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BD, BE, BG, BO, BR, BZ, CA, CH, CL, CN, CR, CY, CZ, DE, DK, DO, DZ, EE, ES, FI, FR, GB, GH, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IS, IT, JO, JP, KE, KR, KW, LK, LT, LU, LV, MA, MX, MY, NG, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, UA, UY, VN, ZA |
| Quantity | 112 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04953170383533 |
| Model numbers | TB-0545FCS |
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423510 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).
Reason for recall
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
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-1000-2025. 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.