Food, drugs, devices › Gyrus Acmi, Incorporated
Device recall: PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
FDA enforcement event 63629 is a device recall by Gyrus Acmi, Incorporated of Southborough, MA, initiated 17 Oct 2012 and classified Class II, with 1 product record.
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. 88% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 9 Apr 2013. 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
"One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer."
Distribution
"Worldwide distribution: USA state of Kansas and country of Korea."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0411-2013 | PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube | 10 boxes/60 units | Class II | Terminated | 28 Nov 2012 |
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 |
| 8 May 2015 | Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft an | Device | Class II | 2 |
| 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 |
All 5 events for Gyrus Acmi, Incorporated
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer."
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: "Worldwide distribution: USA state of Kansas and country of Korea."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 9 Apr 2013. "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.