Gyrus ACMI recalls Diego Elite Turbinate Blades (BB404:4mm curved) due to potential RF energy activation when used with consoles. All units are affected. No remedy specified in recall notice.
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Gyrus ACMI is recalling Diego Elite Turbinate Blades (4mm curved, product BB4040SS) because they may activate RF energy when used with Diego Elite consoles. This could cause unintended tissue damage during surgery. The recall affects all units sold.
The blades may activate RF energy when used with Diego Elite consoles, potentially causing unintended tissue damage during surgery. This happens because the blades can inadvertently trigger the RF energy feature without proper safety checks.
Surgical professionals using Diego Elite Turbinate Blades with Diego Elite consoles are affected. Patients undergoing procedures with these blades face the highest risk.
Check for the product number BB4040SS on the blade packaging. All lot numbers are affected. The blades are 4mm curved and part of Diego Elite Turbinate Blades.
Look for product number BB4040SS on the blade packaging to confirm if it's recalled.
The recall notice does not specify a remedy.
All Diego Elite Turbinate Blades with product number BB4040SS are affected.
The recall does not specify a stop-use instruction, so no immediate action is required beyond checking product details.
We’ve drafted a message you can send Gyrus ACMI to request your refund or repair — edit it as you like.
Subject: Recall Z-1182-2019 — Gyrus ACMI Gyrus ACMI Hello, I own a Gyrus ACMI that is covered by recall Z-1182-2019 from Gyrus ACMI. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
