FDA Device recall Z-1853-2026
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm
- FDA Device
- Class II
- ongoing
- Published 2026-04-29
On 2026-04-29 the FDA classified a Class II recall of Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm by Olympus, citing potential for detachment of a distal tip component of the device during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1853-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-23 |
| Published | 2026-04-29 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Olympus |
| Distribution | n/a |
Product
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
Reason
Potential for detachment of a distal tip component of the device during use.
Identifiers
| code_info | Model Number: TB2-0535FC. UDI-DI: 04953170440014. All Lot Numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-10-07 · Olympus - Olympus M3 Gold Autoclavable Foroblique Telescope 30
FDA Device · Class II · 2026-10-07 · Olympus - Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector
FDA Device · Class II · 2026-09-30 · Olympus - Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm
FDA Device · Class II · 2026-09-30 · Olympus
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1853-2026%22
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