Diego Elite Turbinate Blades Bipolar Blade — Class II medical device recall Z-1183-2019
Terminated recall by Gyrus ACMI, Inc., reported 2019-04-24, distributed nationwide. Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego
| Recall number | Z-1183-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gyrus ACMI, Inc., Bartlett, TN, United States |
| Recall initiated | 2019-03-08 |
| Classified | 2019-04-17 |
| Reported by FDA | 2019-04-24 |
| Terminated | 2020-05-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, JP, SG |
| Quantity | 13 |
Product
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC
Reason for recall
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
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-1183-2019. 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.