Gyrus Acmi, Incorporated: Medical Device Recall in 2015 - (Recall #: Z-1753-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 8, 2015

Date Posted: June 17, 2015

Recall Number: Z-1753-2015

Event ID: 71238

Reason for Recall:

Potential lack of sterility assurance.

Status: Terminated

Product Quantity: 22,250 boxes

Code Information:

Lot Number: JC24165

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated