CLASS II Device recall · Reported 24 Apr 2019 · FDA Enforcement Report

Diego Elite Turbinate Blades Bipolar Blade curved recalled by Gyrus ACMI

Gyrus Acmi is recalling Diego Elite Turbinate Blades Bipolar Blade curved, Product Number:BB4040SS, distributed nationwide in the US. The recall was initiated on 8 Mar 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lot numbers

Quantity recalled247

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1182-2019
FDA event ID: 82451
Recalling firm: Gyrus Acmi, Bartlett, TN
Classification: Class II
Status: Terminated
Recall initiated: 8 Mar 2019
FDA classified: 17 Apr 2019
Reported: 24 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

8 Mar 2019	Recall initiated by company
17 Apr 2019	Classified by FDA	+40 days
24 Apr 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades

Product as listed by the FDA

Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS

Where it was distributed

Nationwide Foreign: Germany,Japan, Singapore

Nationwide

Questions about this recall

Why was it recalled?

Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades

Which lots are affected?

All lot numbers

Where was it sold?

Nationwide Foreign: Germany,Japan, Singapore

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

9 other products · FDA event 82451

This product is part of a recall event; the main page for the event is Diego Elite Turbinate Blades:Bipolar Blade straight recalled.

Reported	Class	Recall	Company	Reason	Where
24 Apr 2019	CLASS II	Diego Elite Turbinate Blades:Bipolar Blade straight recalled	Gyrus Acmi	Other	Nationwide
24 Apr 2019	CLASS II	Diego Elite Turbinate Blades Bipolar Blade curved recalled by Gyrus ACMI	Gyrus Acmi	Other	Nationwide
24 Apr 2019	CLASS II	Diego Elite Turbinate Blades Bipolar Blade curved recalled by Gyrus ACMI	Gyrus Acmi	Other	Nationwide
24 Apr 2019	CLASS II	Diego Elite Blades Monopolar Straight, TIA Product recalled	Gyrus Acmi	Other	Nationwide
24 Apr 2019	CLASS II	Diego Elite Turbinate Blades Bipolar Blade straight recalled	Gyrus Acmi	Other	Nationwide
24 Apr 2019	CLASS II	Diego Elite Turbinate Blades Bipolar Blade curved recalled by Gyrus ACMI	Gyrus Acmi	Other	Nationwide
24 Apr 2019	CLASS II	Diego Elite Malleable Standard Monopolar Blades Product recalled	Gyrus Acmi	Other	Nationwide
24 Apr 2019	CLASS II	Diego Elite Turbinate Blades Bipolar Blade straight recalled	Gyrus Acmi	Other	Nationwide
24 Apr 2019	CLASS II	Olympus Diego Elite Console Mdcons recalled by Gyrus ACMI	Gyrus Acmi	Other	Nationwide

More recalls from Gyrus Acmi

All 17

Reported	Class	Recall	Company	Reason	Where
24 Apr 2019Device	CLASS II	Olympus Diego Elite Console Mdcons recalled by Gyrus ACMI	Gyrus Acmi	Other	Nationwide
24 Apr 2019Device	CLASS II	Diego Elite Turbinate Blades Bipolar Blade straight recalled	Gyrus Acmi	Other	Nationwide
24 Apr 2019Device	CLASS II	Diego Elite Malleable Standard Monopolar Blades Product recalled	Gyrus Acmi	Other	Nationwide
24 Apr 2019Device	CLASS II	Diego Elite Turbinate Blades Bipolar Blade curved recalled by Gyrus ACMI	Gyrus Acmi	Other	Nationwide
24 Apr 2019Device	CLASS II	Diego Elite Turbinate Blades Bipolar Blade straight recalled	Gyrus Acmi	Other	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide