Gyrus Acmi, Incorporated: Medical Device Recall in 2013 - (Recall #: Z-1439-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear.

Product Classification:

Class II

Date Initiated: May 24, 2013

Date Posted: June 12, 2013

Recall Number: Z-1439-2013

Event ID: 65255

Reason for Recall:

lack of sterility assurance

Status: Terminated

Product Quantity: 100 boxes of 6 units

Code Information:

JC477666

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and countries of: Canada and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated