FDA Device recall Z-1372-2026
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
- FDA Device
- Class II
- ongoing
- Published 2026-02-25
On 2026-02-25 the FDA classified a Class II recall of Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S by Olympus, citing firm is initiating a removal due to continued reports of adverse events.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1372-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-22 |
| Published | 2026-02-25 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Olympus |
| Distribution | US |
Product
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
Reason
Firm is initiating a removal due to continued reports of adverse events.
Identifiers
| code_info | Model No. TB-0535FCS; UDI: 04953170383564, 04953170383557, 04953170409677, 04953170383540; All Lots. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1372-2026%22
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