Food, drugs, devices › Gyrus Acmi, Incorporated
Device recall: Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft an
Gyrus Acmi, Incorporated (Southborough, MA) initiated this device recall on 8 May 2015; FDA lists 2 product records under event 71238, classified Class II.
FDA defines Class II as 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. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 17 May 2016. Initiation: voluntary: firm initiated. Gyrus Acmi, Incorporated has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Gyrus Acmi, Incorporated, Southborough, MA.
Reason for recall
"Potential lack of sterility assurance."
Distribution
"Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1752-2015 | 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 & Neck procedures. Catalog No. TS100S, Lot numbers JC929332 and below, Rx Only, STERILE EO | 12,020 boxes | Class II | Terminated | 17 Jun 2015 |
| Z-1753-2015 | 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 | 22,250 boxes | Class II | Terminated | 17 Jun 2015 |
Context
Other enforcement events for Gyrus Acmi, Incorporated
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 17 Apr 2018 | Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists | Device | Class II | 1 |
| 21 Oct 2014 | Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). | Device | Class II | 1 |
| 24 May 2013 | GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 1 | Device | Class II | 1 |
| 17 Oct 2012 | PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube | Device | Class II | 1 |
All 5 events for Gyrus Acmi, Incorporated
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Potential lack of sterility assurance."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 17 May 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.