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Gyrus Acmi, Incorporated Recalls
6 recalls on record · November 28, 2012 to June 6, 2018 · Medical Devices
Recalls by year
12
13
14
15
18
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
June 6, 2018Medical DevicesFDA
Gyrus Acmi, Incorporated recalls Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consis
Hazard: There is a potential for the cord to spark and cause a fire.
June 17, 2015Medical DevicesFDA
Gyrus Acmi, Incorporated recalls Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft an
Hazard: Potential lack of sterility assurance.
June 17, 2015Medical DevicesFDA
Gyrus Acmi, Incorporated recalls Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft an
Hazard: Potential lack of sterility assurance.
December 3, 2014Medical DevicesFDA
Gyrus Acmi, Incorporated recalls Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan).
Hazard: All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging that could be associated with bacterial contamination that might lead to patient infection.
June 12, 2013Medical DevicesFDA
Gyrus Acmi, Incorporated recalls GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 1
Hazard: lack of sterility assurance
November 28, 2012Medical DevicesFDA
Gyrus Acmi, Incorporated recalls PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy
Hazard: One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer.