Gyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk
Gyrus ACMI is recalling Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with Olympus consoles.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (unintended RF energy activation) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Gyrus ACMI, Inc. is recalling 1,333 units of the Diego Elite Turbinate Blades Bipolar Blade, 4mm straight (Part Number: BB4000SS). The recall covers all lot numbers of this specific product.
The recall is being issued because the blades may inadvertently permit the activation of the radiofrequency (RF) energy feature when used with Olympus Diego Elite Consoles. This unintended activation presents a potential safety risk to patients and medical professionals.
The affected products were distributed nationwide and in Germany, Japan, and Singapore. Users of these devices should stop using the recalled blades and contact the manufacturer for further instructions on replacement or return.
The recalled product
- Product
- Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS
- Manufacturer
- Gyrus ACMI, Inc.
- Affected units
- 1,333
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Gyrus ACMI, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
Same manufacturer · Gyrus ACMI, Inc.
See all →- HighOlympus Diego Elite Console Recall for Unintended RF Energy Activation
FDA (Devices) · 2019-04-24
- SevereGyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Energy Risk
FDA (Devices) · 2019-04-24
- HighGyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk
FDA (Devices) · 2019-04-24
- HighGyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk
FDA (Devices) · 2019-04-24
- SevereGyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk
FDA (Devices) · 2019-04-24
Same hazard · unintended activation
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FDA (Devices) · 2026-06-10
- Severe
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- HighPacemaker packs recalled over smoke pencils that can remain active
FDA (Devices) · 2025-11-26
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FDA (Devices) · 2025-11-26
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