FDA Device recall Z-1184-2019
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
- FDA Device
- Class II
- terminated
- Published 2019-04-24
On 2019-04-24 the FDA classified a Class II recall of Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS by Gyrus Acmi, citing olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1184-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-08 |
| Published | 2019-04-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Gyrus Acmi |
| Distribution | US |
Product
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
Reason
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Identifiers
| code_info | All lot numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1184-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.