Gyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk
Gyrus ACMI is recalling 82 Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with Olympus consoles.
What this means for you
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 involves a medical device defect that poses a risk of harm (unintended RF energy activation) but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Gyrus ACMI, Inc. is recalling 82 units of the Diego Elite Turbinate Blades, specifically the Bipolar Blade, 4mm straight, Part No: BB4000SC. 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 RF energy feature when used with Olympus Diego Elite Consoles. This defect presents a risk of unintended energy delivery during medical procedures.
The affected products were distributed nationwide as well as in Germany, Japan, and Singapore. Users of these medical devices should stop using the recalled blades and contact Gyrus ACMI, Inc. for instructions on how to return or replace the product.
The recalled product
- Product
- Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC
- Manufacturer
- Gyrus ACMI, Inc.
- Affected units
- 82
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 energy activation
See all →- HighGyrus ACMI Recalls Diego Elite Malleable Monopolar Blades
FDA (Devices) · 2019-04-24
- SevereGyrus ACMI Recalls Diego Elite Blades Due to RF Energy Activation Risk
FDA (Devices) · 2019-04-24