CLASS II Device recall · Reported 17 Jun 2015 · FDA Enforcement Report

Diego Elite Tubeset, intended for cutting, coagulation recalled

Gyrus Acmi is recalling Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal, distributed nationwide in the US. The recall was initiated on 8 May 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: JC24165

Quantity recalled22,250 boxes

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-1753-2015
FDA event ID: 71238
Recalling firm: Gyrus Acmi, Southborough, MA
Classification: Class II
Status: Terminated
Recall initiated: 8 May 2015
FDA classified: 11 Jun 2015
Reported: 17 Jun 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

8 May 2015	Recall initiated by company
11 Jun 2015	Classified by FDA	+34 days
17 Jun 2015	Published in enforcement report	+6 days

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

Reason for recall

Potential lack of sterility assurance.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head and Neck procedures. Catalog No. TS101DC, Lot numbers JC924165 and below; Rx Only, STERILE EO

Where it was distributed

Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain

Nationwide

Questions about this recall

Why was it recalled?

Potential lack of sterility assurance.

Which lots are affected?

Lot Number: JC24165

Where was it sold?

Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain

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

1 other product · FDA event 71238

Reported	Class	Recall	Company	Reason	Where
17 Jun 2015	CLASS II	Diego Elite Tubeset recalled by Gyrus Acmi, Incorporated	Gyrus Acmi	Sterility	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 curved recalled by Gyrus ACMI	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