THUNDERBEAT — Class II medical device recall Z-0108-2024
Ongoing recall by Olympus Corporation of the Americas, reported 2023-10-18, distributed nationwide. Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediat
| Recall number | Z-0108-2024 |
|---|---|
| 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 | 2023-09-12 |
| Classified | 2023-10-12 |
| Reported by FDA | 2023-10-18 |
| Distributed | Nationwide (US) |
| Quantity | 2,496 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 04953170409677 |
| Lot numbers | KR271978, KR314612, KR314613, KR314615, KR314617, KR314618, KR314619, KR314621, KR314622, KR314623, KR314624, KR314626, KR314627, KR314628, KR314629, KR314630, KR314631, KR314632, KR314633, KR314634, KR314638, KR314640, KR314641, KR314644, KR314647, KR314648, KR314650, KR314651, KR314652, KR314654, KR314655, KR314657, KR314659, KR314660, KR314662, KR314663, KR314668, KR314670, KR314671, KR314672 and 45 more |
| Model numbers | TB-0535FCS |
Product
THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed
Reason for recall
Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery
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-0108-2024. 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.