Gyrus ACMI Recalls Diego Elite Malleable Monopolar Blades
Gyrus ACMI is recalling 161 Diego Elite Malleable 4mm Standard Monopolar Blades because they may allow unintended RF energy activation when used with Diego Elite 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 involves a medical device with a risk of unintended energy activation, which is a risk-of-harm product where specific injury reports are not detailed in the source text, fitting the High severity criteria.
Plain-English summary
Gyrus ACMI, Inc. is recalling 161 units of the Diego Elite Malleable, 4mm Standard Monopolar Blades (Product Code: MM4000SS). The recall covers all lot numbers of this specific product.
The recall is being conducted 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 during medical procedures.
The affected products were distributed nationwide and in foreign markets, specifically Germany, Japan, and Singapore. Healthcare facilities and users of these devices should stop using the recalled blades immediately and contact Gyrus ACMI, Inc. for further instructions on returns or replacements.
The recalled product
- Product
- Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS
- Manufacturer
- Gyrus ACMI, Inc.
- Affected units
- 161
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 →- SevereGyrus ACMI Recalls Diego Elite Blades Due to RF Energy Activation Risk
FDA (Devices) · 2019-04-24
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