TB-0545PC: THUNDERBEAT 5 mm — Class II medical device recall Z-0432-2014
Terminated recall by Olympus America Inc., reported 2013-12-11, distributed nationwide. Complaints of damage to various models of Thunderbeat Hand Instruments during surgical procedures, including c
| Recall number | Z-0432-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus America Inc., Center Valley, PA, United States |
| Recall initiated | 2013-09-27 |
| Classified | 2013-12-05 |
| Reported by FDA | 2013-12-11 |
| Terminated | 2015-02-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 8,709 |
| Reason classes | packaging |
Product
TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0 em, In line Grip TB-545FC: THUNDERBEAT 5 mm, 45 em, Front Actuated Grip TB-0535FC: THUNDERBEAT 5 mm, 35 em, Front Actuated Grip The Olympus Thunderbeat Surgical Tissue Management System ("Thunderbeat") is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
Reason for recall
Complaints of damage to various models of Thunderbeat Hand Instruments during surgical procedures, including cracking, breaking, or deformation of the components of the probe tip or jaw.
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-0432-2014. 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.