Gyrus ACMI Recalls Diego Elite Blades Due to RF Energy Activation Risk
Gyrus ACMI, Inc. is recalling Diego Elite Blades Monopolar 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant injury risks such as unintended energy activation.
Plain-English summary
Gyrus ACMI, Inc. is recalling 318 units of Diego Elite Blades Monopolar, 4mm Straight, TIA (Product Code: MB4000SS). The recall covers all lot numbers and includes units distributed nationwide as well as in Germany, Japan, and Singapore.
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 issue could lead to unintended energy delivery during use.
Healthcare professionals and consumers should stop using the affected blades immediately. Users should contact Gyrus ACMI, Inc. for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS
- Manufacturer
- Gyrus ACMI, Inc.
- Affected units
- 318
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 →- SevereGyrus 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 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
- HighGyrus 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
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